Total 55 job vacancies by Pharmagend Global Medical Services Pte. Ltd.

Job Summary: The Assistant Finance Manager (AFM) supports the head of finance in managing the financial operations of a pharmaceutical manufacturing plant. The AFM is responsible for financial reporting, costing, budgeting, forecasting, and analysis to ensure accurate and timely financial information. The role also involves supporting strategic financial planning and ensuring compliance with regulatory standards.

Key Responsibilities:

• Preparing monthly, quarterly, and annual financial statements and reports.
• Managing accounts payable processes, ensuring timely and accurate processing.
• Develop and maintain standard costs for products and processes and analyse manufacturing costs and prepare detailed cost reports.
• Support the development and management of the periodic, annual budget and financial forecasts.
• Monitor budget variances and provide analysis and recommendations for cost control.
• Conduct financial analysis to support business decisions, including cost analysis, profitability analysis, and variance analysis.
• Ensure compliance with financial regulations, accounting standards, and internal policies.
• Identify and implement process improvements to enhance financial operations and reporting efficiency.
• Support the implementation of SAP Hana system.
• Work closely with other departments to gather financial and required information.
• Assist in various ad-hoc projects and tasks as needed.

Qualifications:

• Bachelor’s degree in finance, accounting, or related field and professional certification is preferred.
• 5+ years of experience in audit, finance or accounting, preferably in the pharmaceutical or manufacturing industry.
• Strong knowledge of financial principles, accounting standards, and regulatory requirements.
• Proficiency in SAP Hana is preferred.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.

Job Summary:

We are looking for a friendly, organized, and professional Receptionist to join our team. The ideal candidate will be the first point of contact for visitors and clients, providing a welcoming and efficient experience.

Key Responsibilities:

• Greet and welcome guests as soon as they arrive at the office.
• Direct visitors to the appropriate person or department.
• Answer, screen, and forward incoming calls in a polite and professional manner.
• Maintain the reception area, ensuring it is tidy, presentable, and equipped with necessary materials (e.g., pens, forms, visitor logs).
• Schedule appointments and manage meeting room bookings.
• Assist in distributing parcels and post mail, ensuring timely delivery to the intended recipients.
• Coordinate with other departments to ensure smooth office operations.
• Maintain security by following procedures, monitoring logbooks, and issuing visitor badges.
• Manage office supplies and order replacements when necessary.
• Provide general support to office staff as needed.

Qualifications:

• High school diploma or equivalent (additional certification in Office Administration is a plus).
• Proven work experience as a Receptionist, Front Office Representative, or similar role.
• Excellent communication skills (both written and verbal).
• Ability to multitask and manage time effectively.
• Proficiency in MS Office (Word, Excel, Outlook).
• Basic knowledge of office equipment (printers, scanners, etc.).

KEY DUTIES AND RESPONSIBILITES:

• Perform receipt of incoming raw and packaging materials.
• Maintain and update documents related to Delivery- Acknowledge, Goods Receipt Note along with supporting documents.
• Ensure that materials are kept as per the storage conditions.
• Perform dispensing and sieving of raw materials for production use.
• Perform cleaning of accessories used and the dispensing booth I area after completion of the dispensing / sieving activities.
• Issue packaging materials for packing use.
• To give the planned output dispensing and sieving of raw materials.
• Regularly verify physical stock, review against system stock and identify discrepancies.
• Perform performance checks for the weighing balances as required). Coordinate for calibration / preventive maintenance for all Warehouse equipment and instruments.
• Intimate and follow up with Maintenance department for breakdown rectification of Warehouse equipment.
• To ensure maintenance of Warehouse area and equipment in the state of cleanliness as per SOP.
• Assist in performing routine check and ensure proper cleaning of premises by contract cleaner.
• Assist in investigation in case of any process deviation, non-compliance.
• To carry out preventive and corrective actions for observed non-conformances.
• Assist in installation and qualification of Warehouse equipment.
• Ensure compliance to GxP /Safety/ HSE / Quality policies.
• To coordinate with QC for sampling of raw and packaging materials. Arrange sampling activity and cleaning of sampling booth.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Good understanding of safe working practices and cGMP.
• A good team playerwith positive learning attitude.
• Willing to work in Tuas area, in warehouse and dispensing environment.

EDUCATION & EXPERIENCE

• Minimum GCE 'O' level or NITEC or Higher NITEC or Diploma in Warehouse/ Logistics or relevant disciplines
• Preferably with 3 years' relevant experience in pharmaceutical manufacturing warehouse/ store operation.
• Entry level NITEC / Higher NITEC / Diploma candidates are welcome to apply.

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.

KEY DUTIES AND RESPONSIBILITES:

· Perform various activities and tasks required in the tablet and capsule final packing equipment.

· Operate all relevant equipment, clean, assemble and maintain the cleanliness of the equipment.

· Perform and maintain the documentation of operations in accordance with cGMP requirement.

· Operate the equipment appropriately in accordance with Standard Operating Procedure / batch document.

· Perform online monitoring of in process parameters / checks throughout the batch.

· Complete all relevant records and other documentation required for packing and related equipment in the work area.

· Perform all activities in accordance with cGMP.

· Maintain the cleanliness of work area to ensure cGMP compliance.

· Perform all other relevant duties required to meet the schedule.

· Check relevant material and product details against batch document.

· Co-ordination with Engineering for break down rectification of both primary and secondary packing lines

· Involve in equipment / process qualification.

· Participate in investigation of process deviation, cGMP and all other compliance related matters, where applicable.

· Ensure compliance with GxP / Safety / Quality policies.

REQUIREMENT

· Good understanding of safe working practices and cGMP.

· Experience in bottle or blister oral solid dosage packing is preferred.

· A good team player with a positive learning attitude.

· Willing to work in Tuas area, in cleanroom environment with full gowning.

EDUCATION & EXPERIENCE

· Minimum GCE 'O' level or NITEC or Higher NITEC or Diploma in Biotechnology / Biomedical / Mechanical / Mechatronics Engineering or relevant disciplines

· With 2-5 years of manufacturing experience in Pharmaceutical or related industries.

· Entry level NITEC / Higher NITEC / Diploma candidates are welcome to apply.

1. To lead site production and engineering projects and act as project coordinator as a main responsibility and keep continuous tracking of projects. Must have proficiency / experience in the Microsoft project software and project tracking.
2. 5-10 years of experience in the green field / brown field area project management.
3. Capability handles the project from USD 2-5 million.
4. Certified Project management professionals shall be preferred.
5. Planning and follow up all new and retrofit projects of Oral formulations for the manufacturing site.
6. Responsible for development of SOPs, quality standard, development and execution of Qualification protocols with following site QMS procedures.
7. Person shall have AutoCAD proficiency.
8. Responsible for managing a team of vendors / contractors.
9. Techno commercial evaluations of consultants, vendors, and contractors.
10. Coordinating with statutory authorities for relevant approvals.
11. Complying with operational and personnel standards, regulatory and statutory requirement to ensure efficient, reliable, and uninterrupted operation.
12. Ensuring best available technologies are incorporated by design.
13. Delivering the project within the budget and timeline approved.
14. Ensure smooth handing over of the project to end-users, coordinate and ensure deliverables as per plan.
15. Ensure to maintain the highest standards for cGMP requirements for the manufacturing site.
16. Ensure to meet the required regulatory requirements (e.g. HSA, FDA etc.) and keep the site audit ready all the time.
17. Achieve financial objectives through efficient project management.

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.

Key Responsibilities:

• Assist in the preparation of financial statements, reports, and summaries.
• Perform routine data entry and maintain accurate financial records.
• Reconcile accounts, including bank statements, credit card statements, and vendor accounts.
• Assist with the processing of invoices and payments.
• Prepare and maintain financial spreadsheets and databases.
• Provide support for month-end and year-end closing processes.
• Assist in managing financial transactions and ensuring compliance with company policies.
• Liaise with other departments to gather financial information.
• Support the finance team with any ad-hoc tasks and administrative duties as required.

Key Requirements:

• Diploma or Bachelor’s degree in Accounting, Finance, or a related field (or equivalent work experience).
• Previous experience in a finance or accounting role is preferred.
• Proficient in Microsoft Excel; experience with financial software (e.g., QuickBooks, SAP) is a plus.
• Strong attention to detail and accuracy.
• Good communication and organizational skills.
• Ability to manage multiple tasks and work independently.
• Positive attitude and willingness to learn.
• Available to start immediately or within a short notice period.

KEY DUTIES AND RESPONSIBILITES:

· Collaborate with key account managers to identify new business and grow relationships that assist in revenue generation for the organisation.

· Support or lead development initiatives of the identified new business strategies / opportunities.

· Develop and prioritize a list of target prospective clients for specific service sales and a strategy to achieve defined sales targets.

· Pursuing and opening a line of dialogue with prospective clients.

· Develop a strong relationship with the potential client’s relevant contact person, organize visits to the client’s facilities or to our facilities, showcasing our capabilities and identifying the service requirements.

· Develop sales performance metrics based on organisation service prices and cost structure approach.

· Securing a position to tender or quote for upcoming work with new potential and existing clients.

· Ensure the timely preparation of proposals for our CDMO & CMO services and efficient conclusion of manufacturing service agreement.

· Work with operations team to develop the potential and existing client’s required activities within target markets.

· Partner with operations and service delivery teams to develop accurate and timely quotations and proposals for your clients.

· Establish continuous market monitoring, identify trends, and liaise with operations team to develop new solutions.

· Maintain current knowledge of service capabilities and relationship network of stakeholder throughout the Organization.

· Develop intervention strategies to mitigate gaps in delivery of logistics services. Monitor any lapses in delivery of logistics services to clients.

· Any other activities as and when assigned by the Superior.

REQUIREMENTS:

· Excellent verbal / written communication and technical presentation skills.

· Interpersonal skills with the ability to interact with all levels of management, consultants, and clients, with highly developed presentation, negotiation, and persuasion skills.

· Possess extensive and recent experience in a similar senior sales position within the life sciences sector (preferably with a focus on CDMO & CMO services).

· Results focused, commercially aware, creatively and ability to understand clients’ and the organization operational requirements.

· Ability to develop innovative solutions for clients and have a strong aptitude to convert strategy into results for the organization.

· Ability to travel, present and promote capabilities, express initiatives and foster effective positive communication between clients and the organization.

· Ability to work independently with limited supervision.

EDUCATION & EXPERIENCE:

· Minimum Bachelor of Science in biology, chemistry, biochemistry, microbiology, or similar relevant education.

· At least 6-8 years of relevant industry sales/business development experience.

· Knowledge of Formulation Development and Manufacture of pharmaceuticals.

· Experience in a Contract Development and Manufacturing Organization (CDMO) or Contract Manufacturing Organization (CMO) is an advantage.

KEY DUTIES AND RESPONSIBILITES:

• Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
• Preparation of reagents/diluents/ dissolution media as per STP.
• Perform various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
• Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
• Ensure implementation of SOP for all corresponding activities.
• Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
• Ensure real time documentation, maintain data integrity and appropriate traceability.
• Assist in maintenance and calibration of test instruments per specifications.
• Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
• Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
• Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
• Responsible for QC lab and equipment/instrument cleanliness.
• Responsible for procuring and receipt of QC lab glassware and consumables.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Possess working knowledge of GMP in the pharmaceutical industry.
• A good team player with a positive learning attitude.
• Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
• EDUCATION & EXPERIENCE
• Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering).
• (Specialist) Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.
• (Analyst) Fresh grad/ 1-2 years of quality control experience in pharmaceutical manufacturing industry.

• Responsible for office’s day to day HR & administrative related work duties
• Posting job advertisements for vacancies and coordinate interview with candidates.
• Managing employee and company insurance.
• Prepares employees for assignments by establishing and conducting orientation (fingerprint registration) and training programs.
• Responsible for up-to-date employee data TMS record.
• Prepare and coordinate worker's work permit application / renewal / cancellation.
• Coordinate HR events and staff welfare activities
• Assist in admin duties such as staff leave administration and medical claims.
• Manage and supervise the Office Admin functions such as office supplies, equipment, facilities repairs and maintenance.
• Liaison with inter-departments on necessary work coordination.
• Assist in travel arrangements and accommodation bookings for employees and visitors.
• Other duties as assigned by management.

Requirements:

• At least 3 years of relevant working experience in the related field.
• Good in written communication.
• Computer literate with strong proficiency in Microsoft Office applications.
• Good knowledge of Employment Act, MOM regulations and practices
• Experience in HR software will be advantages

1. Lead a performing Engineering team covering utilities, facilities, and warehouse for the manufacturing site.
2. Achieve financial objectives through efficient utility operation, cost improvement actions and optimal cost options.
3. Planning & execution of all new and retrofit projects related to utilities & facilities.
4. Ensuring the best available technologies are incorporated by design.
5. Techno commercial evaluations of consultants, vendors, and contractors.
6. Delivering the project within the budget and timeline approved.
7. Responsible for relevant project costing and annual budget preparation related to engineering, facilities and EHS.
8. Coordinating with statutory authorities for relevant approvals.
9. Complying with operational and personnel standards, regulatory and statutory requirements to ensure efficient, reliable, and uninterrupted operation.
10. Ensure smooth handing over of the project to end-users, coordinate and ensure deliverables as per plan.
11. Ensure the site's facilities are kept to the highest standards for cGMP requirements, including Purified water system, HVAC system, EMS, BMS,Boilers, fire safety, security, pest control, cleaning services and waste removal.
12. Responsible for utilities & Facilities equipment Operation, Maintenance, Calibration, spares management and drawings management.
13. Responsible for development SOPs and quality standard for site with following of site QMS procedures.
14. Ensure to meet required the regulatory requirements (e.g. HSA, FDA etc.) and keep site audit ready all the time.
15. Responsible for managing a team of vendors / contractors.
16. To assist on any ah-hoc duties that been assigned / task by the immediate superior.

Qualification

1. Degree or Diploma in Engineering with a minimum of 5-10 years of relevant experience.
2. SCEM will be an added advantages.

KEY DUTIES AND RESPONSIBILITES:

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.

• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.

• Candidate must have knowledge and experience of qualification/validation principles and their practical application.

• Preparation and review of process and cleaning validation protocols and reports.

• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.

• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.

• Write, review, and revise validation SOPs in compliance with regulatory guidelines.

• QA oversight and/or review during the validation process.

• Manage incidents and deviations related to validation & qualification.

• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.

• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.

• Cross train and develop expertise in other areas of validation.

• Must be able to interact and lead effectively in a team-based environment.

• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE:

• Degree a scientific discipline or equivalent.

• Experience in a regulated industry preferred.

• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

KEY DUTIES AND RESPONSIBILITES:

• Perform various activities and tasks required in the tablet coating production areas.

• Operate all relevant equipment, clean, assemble and maintain the cleanliness of the equipment.

• Perform and maintain the documentation of operations in accordance with cGMP requirement.

• Operate the equipment appropriately in accordance with Standard Operating Procedure / batch document.

• Perform online monitoring of in process parameters / checks throughout the batch.

• Complete all relevant records and other documentation required for tablet coating, maintenance and cleaning of equipment in the work area.

• Perform all activities in accordance with cGMP.

• Maintain the cleanliness of work area to ensure cGMP compliance.

• Perform all other relevant duties required to meet the schedule.

• Check relevant material and product details against batch document

• Co-ordination with Engineering for break down rectification of coating and related solution mixing equipment.

• Involve in equipment / process qualification.

• Participate in investigation of process deviation, cGMP and all other compliance related matters, where applicable.

• Ensure compliance to GxP / Safety / Quality policies.

REQUIREMENT

• Good understanding of safe working practices and cGMP.

• Experience in tablet coating of oral solid dosage manufacturing is preferred.

• A good team player with positive learning attitude.

• Willing to work in Tuas area, in cleanroom environment with full gowning.

EDUCATION & EXPERIENCE

• Minimum GCE 'O' level or NITEC or Higher NITEC or Diploma in Biotechnology / Biomedical / Mechanical / Mechatronics Engineering or relevant disciplines

• With 2-5 years of manufacturing experience in Pharmaceutical or related industries.

• Entry level NITEC / Higher NITEC / Diploma candidates are welcome to apply.

1. Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
2. Preparation of reagents/diluents/ dissolution media as per STP.
3. Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
4. Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
5. Ensure implementation of SOP for all corresponding activities.
6. Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
7. Ensure real time documentation, maintain data integrity and appropriate traceability.
8. Assist in maintenance and calibration of test instruments per specifications.
9. Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
10. Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
11. Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Responsible for procuring and receipt of QC lab glassware and consumables.
14. Any other activities as and when assigned by the Superior.