CSV QA Expert (Pharma/ Validation/ GAMP)
Salary Up to $8,000 depending on experience
Location : Tuas
Industry : Pharmaceutical
Be part of building a next-gen, digitalized manufacturing facility in Singapore using advanced tech like AGVs, cobots, and cloud-based systems.
Job Summary:
- To ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with company's quality requirements and the applicable cGMP regulations.
- Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system [EMS], laboratory information management system [LIMS], batch record management systems [MES], Data Historian), Process Control Systems (e.g., distributed control system [DCS], programmable logic controller [PLC]), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems.
- Support the establishment and maintenance of site's computerized systems validation program.
- Responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.
Key Accountabilities
- Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet company's quality requirements and fulfil regulatory expectations.
- Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, to define and implement a risk-based validation strategy that confirms computerized systems meet intended requirements and function reliably throughout their entire lifecycle, ensuring they are properly qualified and maintained.
- Lead and provide quality oversight for establishing and maintaining site's computerized systems validation program in accordance with current regulatory expectations, company standards, and industry practices.
- Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.
- Author CSV plans and procedures.
- Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.
- Ensure continual improvement of CSV program by performing periodic review of the program.
- Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.
- Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.
- Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.
- Partner and collaborate closely with cross functional teams to achieve site's GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.
Requirements :
- Bachelor's or Master's degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
- A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
- Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.
- Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.
- Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.
- Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
- Good communication skills to present validation strategies to the site management and other functions.
- Experience in greenfield/brownfield facility start-ups will be advantageous.
- Familiar with Digital 4.0 concepts and potential applications in Quality.
- Able to work independently with little supervision.
- Experience with ensuring Data Integrity in computerized systems.
Lim Pey Chyi - [Confidential Information]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
