Total 96 senior manager job vacancies in Quality Assurance / Control category in d22 jurong jurong island tuas

Quality Management System:

• Responsible for quality oversight of operations at PharmaGend Global Medical Services Pte Ltd facility. Adhere to laid down Quality Management System, its effective implementation and facilitate continuous improvement in all manufacturing area activities, and effective resolution of routine Quality issues.
• Tracking, trending and closing QMS events using TrackWise. Review and Approval of documentation associated with key quality compliance indicators - Deviation, Market Complaints, Product Recalls, CAPAs, Change Controls, Returned Goods and other quality system documents e.g., Product Quality Review, SOP's, Protocols, reports as appropriate; and actively participate in investigations.
• Subject matter expert in Qualification and Validation activities related to GMP area, production equipment and key utilities e.g., Purified water system, Compressed air system.
• Review periodically the Quality Performance parameters, review and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators.
• Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
• Ensure timely review and / approval of executed batch records, and final batch release to market. and disposition (Release/Rejection) of in-process and finished product batches as appropriate.
• Implement ongoing process management mechanisms (process mapping, documentation, metrics, monitoring systems and process control techniques).
• Perform periodic review of Quality Performance parameters and approve appropriate remedial actions towards compliance and Quality of products supplied. Identify proactively the actions towards continuous improvement and measure performance of Quality through various tools / Quality Indicators, provide Quality Management Reports.
• Escalate the quality events, trends as appropriate to various management levels in organization for appropriate regulatory actions as applicable and provide close-out actions as deemed necessary / required.
• Conduct internal audits and/or vendor audits as required.
• Ensure the SOPs are in line with the practice and revision thereof if required.
• To ensure that the facility is kept all time ready to handle any regulatory, customer or internal audit.
• Act as a designee to for Head Quality on QMS related matters.

Documentation Compliance:

• Review and approval of master BMR/BPR and issuance of BMR/BPR.
• Control and Management of archived documents.
• Preparation and Review of SOPs/Work instructions and forms related to quality assurance and cross functional departments.
• Review and approval of protocol and reports.
• Ensure effective control of confidential and all technical documents and information networking, timely review and approval of relevant technical documents.

Quality Risk Management:

• Participate in Identification and implement risk approach in validation / qualification area based on overall risk management policy / guidelines to control / mitigate risks.
• Apply risk management tools and techniques.

People Management including Technical Training:

• Assign responsibilities, monitor performance, counsel & provide feedback on team performance, plan & monitor required training and development to ensure a committed & competent team.
• Build strong and positive cross-functional working relationships by working to include them in the improvement activities/training, making sure their needs and requirements are carefully considered.
• Conduct Technical Training (On the Job as well as Classroom) to fellow colleagues, new employees and cross functional team.

Management of interface with Regulators/Customers

• Interact with customers/regulatory bodies in a timely manner to address quality / technical related events to ensure desired outcome and adherence to regulatory commitment and compliance.
• Interpret current Regulatory guidance and implement at site.
• Management technical agreement with ESP and clients.
• Updating GMP Documents as per Regulatory amendments and process requirements.
• Ensure compliance with various regulatory commitments, regulatory requirements and customer requirements as applicable including policies.

Requirements:

• Bachelor’s degree and/or Maste’s degree in Pharmacy or Chemistry.
• At least 10 to15 years of experience, demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• More than 8 years’ experience in pharmaceutical validation, qualification projects.
• In-depth understanding of Manufacturing/Pharma Business
• Strong team leadership skills
• Strong staff coaching and development skills.
• Strong ability to communicate.
• Strong ability to influence in a team environment and collaborate with peers.
• May participate in interactions with various governmental agencies/regulators and external auditors.
• Strong understanding of US FDA regulatory requirements.
• Serves as an active member of the Quality Management Team
• Serves as an expert to identify best practices across the organization, shares and implements as appropriate.
• Interacts with site efforts to ensure consistency in policies and practices.

Job Roles & Responsibilities

• To liaise with all government agencies pertaining to all DG license applications and / or renewals.
• To support various departments in reading SDS to define the appropriate storage locations.
• To carry out periodic reviews of SOP and audit, to ensure that all DG operations are carried out in compliance with applicable local regulatory requirements and policies.
• To support Compliance Manager in managing group ISO documentation and audits.
• To carry out any ad-hoc tasks, projects or assignments assigned from time to time.

Job Requirements:

• At least 3 years of relevant experience in handling DG cargo and well verse in reading SDS.
• Knowledge in DG regulatory matters is a must.
• Keen to learn and willing to take responsibility.
• Able to communicate and work well with various departments to improve work processes.
• At least a Diploma in Chemical science.
• Able to work within short notice.

Benefits:

• Daily Lunch Provided
• Company Transport Provided at designated MRT stations (Lakeside, Boon Lay & Woodlands)
• Medical and Dental benefits
• Attractive Bonus Scheme (AWS, Special Bonus etc.)
• 5 days' work week

Quality Control

• Product Inspections: Conduct and oversee routine inspections and sampling of raw materials, in-process products, and finished goods to ensure they meet the company's and customer-agreed quality specifications. Address deviations or non-conformities, report findings and recommend corrective action plan.
• Testing and Monitoring: Coordinate and monitor chemical, microbiological, and physical testing of products and materials. Ensure all test results comply with product specifications.
• Production Monitoring: Collaborate closely with the production team to monitor quality control at various stages of production. Implement corrective and preventive measures to address process deviations or defects.
• Customer Complaints: Investigate customer complaints related to product quality or safety. Conduct root cause analysis and recommend corrective actions to prevent reoccurrence.

Quality Assurance

• Policy and Procedure Implementation: Enforce QA policies, Standard Operating Procedures (SOPs), and quality control measures to ensure compliance with standards.
• Regulatory Compliance: Ensure the company complies with all relevant food safety regulations and certifications.
• Documentation and Record-Keeping: Maintain accurate records of all quality-related activities, internal audits, external inspections, test results, and corrective actions. Ensure proper document control for QA/QC records.
• Training: Conduct and facilitate training sessions on food safety, good manufacturing practices (GMP), HACCP, and other quality-related topics for production, QA, and QC staff.

Process Improvement

• Process Improvement: Identify areas for improvement within the QA/QC processes. Lead continuous improvement initiatives to enhance product quality and safety, reduce waste, and increase efficiency.
• Data Analysis and Reporting: Analyze quality data and trends to identify patterns of defects or issues. Generate reports on key quality performance indicators (KPIs) through Statistical Process Control.

Cross-Functional Collaboration

• Team Leadership: Supervise and mentor the QA/QC team, ensuring alignment with organizational goals and fostering a quality-focused culture.
• Collaboration with Other Departments: Work closely with production, R&D, procurement, and logistics to ensure a cohesive approach to product quality and safety. Provide input into new product development and specification setting.

Quality Assurance Manager closely organize and manage the Quality Assurance Department by collecting and reporting accurate study data to ensure that quality of products comply with local authority regulations, protocol requirements and Company's objectives and practices.

1. To evaluate the staff performance on their quality and efficiency based on the work assignment given.

2. To review job contribution of the staff and appraise based on the expectation communicated and quality of work done.

3. To develop and recommend the KPI used to appraise staff and get management approval before implementing.

4. To update the departmental scope from time to time by studying trends in and developments in quality management and translate into a KPI.

5. To ensure ongoing compliance with the PIC/S Guideline for GMP.

6. To achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvement; implementing change.

7. To effectively develops, coaches and manages a team a team of quality professionals of Singapore and Malaysia to implement cGMP requirements as per PICs or other recognised reference and continuous improvement in quality operations.

8. Develops and implements a practical system for Quality Management System activities to facilitate smooth, timely workflows in the performance of job function.

9. To provide leadership, guidance, interpretation, information on regulations, laws and industry guidance that affect pharmaceutical industry.

10. Serve as a SME in matters relating to quality assurance and cGMP.

11. Ensure facility follows applicable quality management directives such as SOPs, manuals, policies, procedures, work instruction, etc.

12. Responsible for reviewing, trending and investigating excursions of environmental monitoring and supportive utilities data.

13. The inspection and investigation of product recalls and product complaints to look into factors which has affect product quality.

14. Acts as the Authorised Person to perform batch release and ensure each batch of medicinal products are manufactured and checked in compliance with the laws in force in the country and in accordance with the requirements of the Marketing Authorisation.

15. Reviews, approves or authorises written procedures and other documents, including amendments.

16. Oversees various quality management systems and analyse trending.

17. Reviews and approves deviations and CAPA.

18. Review, approves and implement changes according to established Change Control procedure.

19. Coordinates and participates in quality risk management activities.

20. Initiates investigation for product complaints, reviews and approves corrective/preventive actions associated.

21. Coordinates product recalls, associated reconciliation, documentation and investigations.

22. Reviews, approves and monitors suppliers of materials.

23. Reviews, approves and monitors contract manufacturers and providers of other GMP related outsourced activities.

24. Ensures validation and qualification are carried out according to schedule.

25. Provides training or ensures appropriate training is provided to QA staffs.

26. Monitors compliance of the organisation with the requirements of Good Manufacturing Practice via Internal Audit.

27. Coordinates management reviews of process performance, product quality and Pharmaceutical Quality System and advocates continual improvement

28. Ensures timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

This role is responsible for conducting test and scheduling/coordinating of testing with other departments to ensure timely delivery of results. This role is also required to perform peer review of laboratory data, support OOS and Deviation investigation.

Responsibilities

• Analysis of final product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods.
• Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).
• Problem solving of analytical methods as well as troubleshooting of equipment.
• Involvement in method transfers and validation.
• Involved in equipment qualification and technical selection of QC equipment and/or standards and reagents.
• Assay trend analysis, document revision and update.
• General lab support includes housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Assay trend analysis, document version and update.
• Independently lead and conduct OOS, deviation investigations. Draft investigations reports.
• Support in team leadership and driving results to meet department KPIs.
• SME in 1 or more areas as aligned with the training plan.
• Able to make decisions independently on the area of expertise.
• Coach and train junior team members.
• Practice and support audit activities
• Any other duties as assigned by your Supervisor/Manager

Experience

• Degree/Diploma in a relevant Science field or Equivalent.
• Understanding and execution of spectroscopy and other assigned methods which may include chromatography methods (HPLC), ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, TOC , Protein Concentration (A280 or SoloVPE), osmolality, potency methods, appearance and other physiochemical methods.
• Work experience preferably Lab experience in a biotech or medically related field
• Relevant experience and accomplishment to dictate final position for which the candidate may qualify
• Good problem solving and analytical skills

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

ST Engineering is a global technology, defence and engineering group with offices across Asia, Europe, the Middle East and the U.S., serving customers in more than 100 countries. The Group uses technology and innovation to solve real-world problems and improve lives through its diverse portfolio of businesses across the aerospace, smart city, defence and public security segments. Headquartered in Singapore, ST Engineering ranks among the largest companies listed on the Singapore Exchange.

Join our Cyber Team

We are an industry leader in cybersecurity with over two decades of experience, we deliver a holistic suite of trusted cybersecurity solutions to empower cyber resilience for government and ministries, critical infrastructures, and commercial enterprises. Backed by our indigenous capabilities and deep domain expertise, we offer robust cyber-secure products and services in cryptography, cybersecurity engineering, digital authentication, SCADA protection, audit and compliance. We specialise in the design and build of security operations centres for cybersecurity professionals and provide managed security services to strengthen the cybersecurity posture of our government and enterprise customers.

We are seeking a Senior QA Engineer who will be responsible for developing and implementing effective QA strategies and methodologies and carry out detailed functional testing to ensure products are well tested before market release. In this role, you will be required to work closely with the development team and product managers to ensure that the products meet the quality standards. You will also be responsible for creating and maintaining test plans and schedules.

Job scope and Responsibilities

• Work with product stakeholders to work out test strategy and create product test plan for new products and maintain the test plans for existing products.
• Perform product inspection and functional testing for quality and conformance to product specifications and deliverables.
• Generate test reports and conduct processes such as data and result archival
• Participating in product quality review meetings with product stakeholders
• Conduct Investigation of internal and customer reports of product quality issues and perform follow up testing, documentation and reporting.
• Monitor and maintain product issue logs and provide updates to managers and product development team.

Requirements & Skills

• Minimum 3 years of experience in product software or system testing
• Experience in leadership roles, especially in QA relevant positions will be favorable
• Strong knowledge of products or software QA methodologies and tools
• Good analytical and troubleshooting skills
• Strong communication and interpersonal skills
• Strong in written communication and report writing
• Ability to work in a fast-paced environment and meet deadlines
• Experience or expertise in any of the following domain areas will be favorable:
  • Networking or networking domain knowledge (CCNA, CCNP) or products e.g. router or switch
  • Software development and/or test automation scripting
  • Cybersecurity domain knowledge (e.g. SSCP, CISSP) or products, e.g. encryption, IDS or firewall products
• Work Location: Jurong East

Find out more: https://www.stengg.com/cybersecurity

ST Engineering believes in fostering a culture where team members are encouraged to overcome challenges, explore new ideas, and work together to succeed. We value individuals who are determined to push beyond the boundaries, and have a thirst for knowledge, continuous learning, and self-improvement.

Job Description

• Carry out troubleshooting and corrective action of instrument breakdown or failures to find out the root cause and best solution in order to restore the functionality get back to normal
• Respond to technical queries from operation personnel and provide advice/solution according to best engineering practice to address issues which affect the operation of the power plant
• Follow C&I work instructions and propose changes for improvement where necessary
• Lead the execution of shutdown works for instrumentation to ensure completion of shutdown work on time
• Work closely with various sections to coordinate cross-functional maintenance works
• Perform risk assessment prior to start of work and conduct on-job risk assessment to identify residual risks associated with the planned/unplanned work
• Monitor spare parts and inventory for critical instrumentation to ensure availability when required in order to minimize unplanned outages. Establish new inventory/cataloging where necessary. Update information in the inventory to ensure that it is relevant for the current operation.
• Provide technical inputs in full cycle of procurement processes for materials and service requisition where required so that all technical requirements are addressed properly to protect company’s interest
• Identify, study, propose, and implement area for improvement in the field of instrumentation engineering to enhance operation and improve overall equipment reliability
• Supervise on-site contractors/additional supplier’s C&I technician(s) as well as C&I vendors to perform site works, review their work procedures and instructions to ensure compliance to achieve highest quality of work in a safe manner
• Participate actively in any meeting, discussion and initiative by team which is relevant to the job role and business needs in order to safeguard company’s interest
• Populate inputs into the Computerized Materials and Maintenance Management System (CMMS) to ensure data and history of equipment maintenance activities are captured accurately. Provide inputs to Planning Engineer with regard to instrument maintenance activities for consolidation

Job Requirements

• Possess a degree in Instrumentation and Control Engineering or Electronics and Electrical Engineering with at least three (3) years of working experience in the instrumentation field, or a diploma in the same fields with at least seven (7) years of working experience in instrumentation field
• Proficient in the codes and standards in the power plant industry i.e. BSI, ISO27001, ANSI, IEC, IEEE, etc.
• Strong interpersonal skills, a team player and able to work with all levels of management and multinational staff
• Hands-on experience in field instrumentation and sensors of different makes
• Proficient in power plant DCS and HMI systems, specifically experience with ABB Advant DCS, GE Alspa DCS will be an advantage
• Proficient in any power plant PLC control system
• Proficient in the P&ID, loop diagram, process functional flow diagram and familiar with gas turbine / steam turbine operations and protection concepts
• Cyber security knowledge in Operation Technology will be an added advantage

Job Description

• Carry out troubleshooting and corrective action of instrument breakdown or failures to find out the root cause and best solution in order to restore the functionality get back to normal
• Respond to technical queries from operation personnel and provide advice/solution according to best engineering practice to address issues which affect the operation of the power plant
• Follow C&I work instructions and propose changes for improvement where necessary
• Lead the execution of shutdown works for instrumentation to ensure completion of shutdown work on time
• Work closely with various sections to coordinate cross-functional maintenance works
• Perform risk assessment prior to start of work and conduct on-job risk assessment to identify residual risks associated with the planned/unplanned work
• Monitor spare parts and inventory for critical instrumentation to ensure availability when required in order to minimize unplanned outages. Establish new inventory/cataloging where necessary. Update information in the inventory to ensure that it is relevant for the current operation.
• Provide technical inputs in full cycle of procurement processes for materials and service requisition where required so that all technical requirements are addressed properly to protect company’s interest
• Identify, study, propose, and implement area for improvement in the field of instrumentation engineering to enhance operation and improve overall equipment reliability
• Supervise on-site contractors/additional supplier’s C&I technician(s) as well as C&I vendors to perform site works, review their work procedures and instructions to ensure compliance to achieve highest quality of work in a safe manner
• Participate actively in any meeting, discussion and initiative by team which is relevant to the job role and business needs in order to safeguard company’s interest
• Populate inputs into the Computerized Materials and Maintenance Management System (CMMS) to ensure data and history of equipment maintenance activities are captured accurately. Provide inputs to Planning Engineer with regard to instrument maintenance activities for consolidation

Job Requirements

• Possess a degree in Instrumentation and Control Engineering or Electronics and Electrical Engineering with at least three (3) years of working experience in the instrumentation field, or a diploma in the same fields with at least seven (7) years of working experience in instrumentation field
• Proficient in the codes and standards in the power plant industry i.e. BSI, ISO27001, ANSI, IEC, IEEE, etc.
• Strong interpersonal skills, a team player and able to work with all levels of management and multinational staff
• Hands-on experience in field instrumentation and sensors of different makes
• Proficient in power plant DCS and HMI systems, specifically experience with ABB Advant DCS, GE Alspa DCS will be an advantage
• Proficient in any power plant PLC control system
• Proficient in the P&ID, loop diagram, process functional flow diagram and familiar with gas turbine / steam turbine operations and protection concepts
• Cyber security knowledge in Operation Technology will be an added advantage

1. Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
2. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
3. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
4. Ensure readiness of QC Laboratory in internal / external audits.
5. Maintain data integrity in Quality Control activities and ensure appropriate traceability.
6. Initiate change control documents.
7. Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
8. Participate in New Product Introduction activities.
9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
10. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
11. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
12. Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
13. Escalate the quality events, trends as appropriate to QC Head.
14. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
15. Serve as subject matter expert on laboratory instrumentation and compliance issues.
16. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
17. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
18. Maintains a safe laboratory environment by implementing recommendations made by EHS.
19. Initiate CAPEX for equipment purchases.
20. Support in budget preparation for QC Laboratory.
21. Any other activities as and when assigned by the Superior.

EDUCATION:

Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).

EXPERIENCE:

Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. Excellent interpersonal and analytical skills, good verbal, and written communication skills.
3. Working knowledge of qualification, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Working knowledge of method development, validation, verification of analytical method.
5. Familiarity of 21 CFR Part 11 requirements.

•Working with Process Engineer & Engineering team on QC requirement.

•Documenting inspection criteria and quality plan.

•Work with QA, Process and Product team on corrective action with quality issue.

•Work with Process team on in-process audit and FQC audit.

•Control of Supplier Quality Assurance (SQA).

•Quality control of in-coming, in-process and out-going products.

•Assist in Project team/Construction team.

•Quality check on finishing work accordance to method of statement

•Prepare and compile report after inspection.

•Plan on construction site visit and liaise with Project Manager or Engineer

•Liaise with Authority for Certification

•Provide Training to workers accordance to method of statement.

Purpose of Position

• Provide maintenance and engineering support for process control systems to ensure safe and reliable operation of the plant.
• Provide technical and engineering support for projects and modifications related to control system to achieve business and operational objectives.

Principle Responsibilities

• Responsible for the maintenance and engineering of all process control systems which may be installed in the plant or externally at customers' site.
• Perform fine-tuning, troubleshooting, modification and programming of the Control System as needed to improve system performance and optimize process operation needs.
• Response to 24-hour emergency call-out and provide night-shift support during plant startup, shutdown and as requested by Operation Team.
• Work closely with the Instrument Team to troubleshoot and resolve instrumentation problems.
• Work with the Project Team to develop requirements and/or specifications of control system for projects and modifications; supervise & implement the project works according to the schedule and requirements.
• Plan and execute preventive and corrective maintenance works for plant turnaround.
• Perform strategy planning for control system expansion, upgrading and renewal.

Job Requirements

• Familiar and hand-on with the engineering tools and programming languages of control systems (Honeywell, Siemens PCS7 and Triconex), able to make program modifications and configuration changes confidently.
• Experienced and familiar with various phases of project works such as engineering, fabrication & construction and commissioning.
• Knowledge and experience with computer system networking, server/client and virtualization architectures.
• Degree in Electronics/Electrical Engineering, major in Control is preferred.
• Minimum 5 years relevant experience working and maintaining Honeywell DCS, Siemens PCS7, Triconex PLC and etc.

Job Description

The Quality Assurance Engineer is responsible to ensure that all products, processes, methods and equipment are validated and is the quality representative in Quality improvement projects. He/She handles external customer complaints and change management business processes. The QA Engineer expected to lead and drive cross functional team in day-to-day issues, global bench marking activities, internal process robustness and automations. He/She must be inclined to have hands-on understanding of tool and product functionality and production.

In this role, you will have the opportunity/responsibility to:

• Continuous improvement of Core Value Drivers and KPI’s in support of quality and business growth through the rigorous deployment of DBS tools
• Manage CAPA & 8D processes; assure root cause analysis and effectively implement robust CAPA in a timely manner. Follow-up and verification of CAPAs to assure no recurrence. Adhere to corporate escalation and reporting guidelines
• Strong focus on variation reduction using data driven approach and automotive core tools such PFMEA, Capability analysis/SPC. MSA etc.
• Proactively identify leading key Indicators and provide Manufacturing Quality Trend Charts/Analysis and suggest/implement improvements based on the trends.
• Support QMS to meet ISO 9001 requirements. Perform Internal Audits per the annual audit schedule, prepare report, follow-up and verification of completion of actions initiated from audit(s)
• Evaluates work methods, procedures and policies. Tracks progress of qualification status and reliability results & determine disposition of non-conforming processes.
• Lead and Support People engagement initiatives both site and global
• Drive efficiency, automation and digitalization in production & QM methods

The essential requirements of the job include:

• Minimum Bachelor’s degree in Engineering/Science
• Min 5 years relevant working experience in manufacturing with 3 years in Quality Control/Assurance in Semiconductor, Electronics or Automotive Manufacturing.
• Solid understanding of quality tools and methods. (FMEA, Control Plan, SPC, 5Why, FTA, 8D, 6 Sigma, Minitab/JMP)
• Certified Quality Engineer or Certified Lead auditor with thorough understanding of ISO 9001 2015 requirements
• Excellent English communication and Interpersonal skills.

It would be a plus if you also possess previous experience in:

• Previous exposure to the Manufacturing sector.
• Excellent problem-solving and analytical skills.
• Analytical and data visualization skills eg Tableau, Qlikview
• Lean / Kaizen proficiency/ black belt proficiency a plus

We are seeking a passionate Senior QA Executive in Food Safety for our brands—CaterCo, Lavish, and Penang Culture—as part of our department expansion! You will be responsible for ensuring all hygiene and food safety standards at the assigned locations.

Responsibilities

• Lead and conduct daily on-site inspections, ensuring compliance with quality standards, food safety regulations, and operational procedures across production and retail outlets.
• Conduct personal hygiene checks, product quality assessments, and sample retention protocols to ensure adherence to internal and external standards.
• Develop, implement, and oversee the laboratory testing and sampling schedules, ensuring all critical tests are conducted in accordance with product specifications and regulatory requirements.
• Analyze test results and recommend corrective actions for any deviations or non-conformities.
• Implementation and continuous improvement of the ISO 22000:2018 Food Safety Management System (FSMS) across all relevant operations.
• Oversee and updates of the Quality Management System and SOPs, ensuring alignment with industry best practices and regulatory changes.
• Work closely with relevant departments to ensure operational adherence to standards, and address any discrepancies.
• Ensure the accuracy, completeness, and proper retention of all quality assurance records, documents, and files as per regulatory and company policies.
• Coordinate with departments to ensure full compliance with quality standards during audits and external inspections.
• Development and continuous improvement of food safety training materials, ensuring they are relevant, up-to-date, and aligned with company policies and industry standards.
• Identify and mitigate quality risks, ensuring proactive measures are taken to prevent non-conformities and quality failures.
• Communicate quality-related issues and improvements to stakeholders, ensuring alignment across all levels of the organization.
• Any other ad-hoc projects assigned by superior.

Requirements

• A level, Diploma or equivalent, in Food Science/ Technology/ any related standard
• Possess knowledge in SFA regulation, ISO 22000, Halal/ any other related standard
• Able to multitask and work within timeline
• Good communication skills
• Team player, proactive and meticulous in work
• Open to working in the West and on weekends

The level of appointment offered will commensurate with candidate's experience.

Interested applicants are invited to apply with your detailed resume via the “Apply Now” option.

We thank you for your interest and regret that only shortlisted candidates will be notified.

We are seeking a passionate Senior Quality Assurance Executive/ Assistant Quality Assurance Manager for our brands—Neo Garden Catering / Deli Hub Catering — as part of our department expansion! You will be responsible for ensuring all hygiene and food safety standards at the assigned locations.

• Lead and conduct daily on-site inspections, ensuring compliance with quality standards, food safety regulations, and operational procedures across production and retail outlets.
• Supervise and conduct personal hygiene checks, product quality assessments, and sample retention protocols to ensure adherence to internal and external standards.
• Develop, implement, and oversee the laboratory testing and sampling schedules, ensuring all critical tests are conducted in accordance with product specifications and regulatory requirements.
• Analyze test results and recommend corrective actions for any deviations or non-conformities.
• Implementation and continuous improvement of the ISO 22000:2018 Food Safety Management System (FSMS) for relevant operations.
• Oversee and updates of the Quality Management System and Standard of Procedure, ensuring alignment with industry best practices and regulatory changes.
• Work closely with relevant departments to ensure operational adherence to standards, and address any discrepancies or audit findings.
• Ensure the accuracy, completeness, and proper retention of all quality assurance records, documents, and files as per regulatory and company policies.
• Perform regular audits of quality documentation and lead the improvement of record-keeping practices.
• Serve as the primary point of contact for external auditors and internal audits.
• Coordinate with departments to ensure compliance with quality standards during audits and external inspections.
• Develop, review, and enhance Standard Operating Procedures (SOPs) across all areas of operations to ensure best practices in quality assurance and food safety.
• Development and continuous improvement of food safety training materials, ensuring they are relevant, up-to-date, and aligned with company policies and industry standards.
• Identify and mitigate quality risks, ensuring proactive measures are taken to prevent non-conformities and quality failures.
• Communicate quality-related issues and improvements to stakeholders, ensuring alignment across all levels of the organization.

Requirements

• A level, Diploma or equivalent, in Food Science/ Technology/ any related standard
• Possess knowledge in SFA regulation, ISO 22000, Halal/ any other related standard
• Able to multitask and work within timeline
• Good communication skills
• Team player, proactive and meticulous in work
• Open to working in the West and on weekends

The level of appointment offered will commensurate with candidate's experience.

Interested applicants are invited to apply with your detailed resume via the “Apply Now” option.

We thank you for your interest and regret that only shortlisted candidates will be notified.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QA Specialist will be responsible for performing day-to-day tasks of the QA Department in a GMP facility manufacturing clinical and commercial pharmaceutical products.

Key responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
• Highly motivated individual and have superior skills in all areas relevant to the job
• Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
• Compile lot genealogy
• Participate actively and approve deviation investigations, utilizing Root Cause tools to enable effective and timely closure of deviation investigations
• Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA
• Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
• Support changeover activities and QA on Call
• Provide training to new members and Participate in walkdown/ QA on Shopfloor and provide feedback to member of cross functional site team(s) on projects / issues
• Superior ability to troubleshoot; able to identify process pathway and work to develop improvement in strategy site team(s) on projects/ issues
• Understanding of advanced topics pertaining to cGMP
• Participate in Regulatory Inspections or Customer Audits as required.
• Identify process pathway and work to develop improvement in strategy
• Help/Transfer and quickly assimilate to leadership role in other process areas
• Assume Supervisory responsibility in absence of supervisor
• Any other tasks as and when assigned by supervisor

Key requirements:

• Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
• Relevant QA Operations background from the Biopharma environment.
• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
• Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7).
• Meticulous and Systematic.
• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.