Total 1,060 Quality Assurance / Control job vacancies in SA - Regional - Clare Valley & Mid North

Quality Assurance Manager

Key Responsibilities
• Serve as the main Quality point of contact related to suppliers
• Manage External site to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements
• Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
• Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
• Provide quality oversight of the manufacturing, testing, and release of materials at External site
• Author and drive actionable site inspection readiness plans
• Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
• Representation at product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
• Identify and mitigate risk at the External site
• Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
• Escalate risks or roadblocks to management
• Drive timely decision making using principles
• Drive continuous improvements

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• Min 5 years relevant experience in a related industry preferred
• Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA/ QO)

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Job Description:

• Conduct full range of audit for listed companies and SMEs, both in Singapore and overseas, from planning to completion, meet deadline consistently, a reliable and well organised team member

• Develop good problem solving skills and provide sound recommendation of management actions based on industry research, insightful analysis and investigation

• Manage stress and emotions under challenging situation - coach junior employees, communicate clearly, share learnings

• Maintain awareness of market trends and indsutry factors impacting the client, to be able to lead non-complex client meeting

Requirements:

• Degree or professional accounting qualifications recognised by ISCA

• Minimum 3 years’ relevant experience with large/mid-tier international accounting firms

• Proactive, committed and able to work under pressure

• Possess initiative and the ability to work independently

• Good communication skills, both oral and written

• Team player - approachable and personal

Responsibilities (include but are not limited to):

• Work with the Manufacturing department as a production area Quality Assurance representative

• Coordinate and facilitate Quality Assurance related production and production related activities

• Ensure timely issuance of production records, procedures and labels

• Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

• Review batch-related documentation, and ensure resolution of issues to release product

• Communicate lot disposition pending issues to Management

• Ensure approval and timely delivery of Final Product

• Ensure that products are manufactured in compliance with regulatory and GMP guidelines

• Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

• Review and approve Manufacturing Production Records

• Compile and verify all batch related documents into a Final Product lot disposition package

• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

• Review and disposition disposable raw materials and components for GMP use

• Review equipment and facility technical and investigation reports

• Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

• Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents

• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA Specialist)

Thank You.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

1. Quality Assurance Specialist Job Description

Reporting to QA Supervisor

Objective of Role

• This position is part of the Quality Assurance team responsible for implementation and maintenance of the various Quality Systems and release of incoming material to achieve the site objectives for the company.

• To build up a pipeline of skilled manpower for Singapore’s biologics manufacturing industry

General responsibilities:

• Participating in investigations relating to laboratories/ incoming material release/ systems and review the

investigation report.

• Participate as SME the gap analysis for current SOP/practices with the various subject matter expert to

ensure compliance with DM/DPs revision, where gaps are identified, ensure that an

implementation/mitigation plan is in place and follow-through to completion.

• Support the compliance, audit, regulatory and training activities as required and any other responsibilities

as assigned by Supervisor

• Leadership

o Build strong partnership with all other departments to ensure open communications and acceptance o Commitment to a fair and respectful relationship to others and behavior in accordance with the company.

Code of Conduct

• EHS

o Responsibility to adhere to any applicable EHS requirements

• Any other duties as assigned by supervisor.

Other responsibilities:

• Quality System(s) implementation and maintenance (if assigned)

o Participate in Quality System(s) rollout by ensuring that the following elements of the Quality System(s) are implemented and maintained at the site according to regulatory, corporate and division requirements:

o Nonconformance/CAPA, Change control, Incoming Release, Quality Management Review, Customer complaints, Annual Product Review/Product Quality Review, Product Recall

o Responsible for the development and writing of Quality systems and QA related procedures • Perform assessments and tasks related to change controls pertaining to Quality System

o Raw Material release (if assigned)

o Responsible for the development and writing of incoming material specifications.

o Ensure timely release of incoming material

o Perform assessments and tasks related to change controls pertaining to incoming release (if assigned)

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• Min 5 years relevant experience in a related industry preferred
• Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA/ QO)

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Quality Assurance Engineer

· Perform Quality Assurance/Quality Engineering to ensure components, finished products and processes meet established specifications.

· Analyse material and processes and make recommendations/ take action to correct deficiencies.

· Troubleshoot equipment and process issues. Summarize and draw conclusions from test results leading to effective technical resolution of process problems.

· Disposition non-conforming material requiring advanced process/technical knowledge. Work directly with suppliers to prevent or correct discrepant material

· Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts).

· Implement corrective and preventative actions.

· Work with Production, Manufacturing/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes.

· Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally

· Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.

· Develop and review documented operating procedures associated with material inspection or processes

Our requirements:

• Min Diploma or Degree in Biomedical Engineering
• Min of 2 years’ experience in QA Biomedical Engineering
• Must possess excellent team work and interpersonal skills with a strong emphasis on good analytical skills
• Possess good customer interactions skills
• Sound ability to troubleshoot and repair
• Good communication skills

If you are interested in the position, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA Engineer)

Thank You.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Duration: 6 months

Salary: $4500 - 8000 (Depending on experience)

Working Hours: 5 days office hours

Job Scope:

• Support the site projects on Qualification/ Validation

Assessment and Approval of Documents

• Responsible to review and approve the Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.

• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.

• Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.

• Provide validation expertise, oversight and support for the development (or modification phases) of Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification.

• Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.

• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.

• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.

• Build strong partnership with all other departments to ensure open communications and acceptance

• Responsibility to adhere to any applicable EHS requirements.

• Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.

• Any other duties as assigned by Manager/ Supervisor.

Job Requirements:

• Min. Degree in any relevant science field preferably in pharmaceutical or life sciences
• Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• Min. 2-3 years relevant experience in pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation.
• Hands-on experience with hands-on experience in performing equipment, process, cleaning, computer systems & shipping validation will be advantages.FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.

For interested applicants, please send your updated resume to: melissa@recruitexpress.com.sg

All candidates’ information will be treated with the strictest confidence

Melissa Zhang Zhiqi (Mezzo)

R2197564

Recruit Express Pte Ltd

99C4599

• Perform a variety of tasks in connection with collecting, storing, examining, weighing, surveying, and distributing linen.
• Collect soiled or contaminated linen from all the wards and clinics within the main hospital facility.
• Ensure that the linen is properly bagged and separated.
• Responsible for distributing various sheets, pajamas, operating scrubs, pillowcases, blankets, towels, and drapes throughout the hospital.
• Exchange soiled or contaminated linen for clean linen throughout outlying branch clinics.
• Ensure linen is always in a clean locked storage area and container.