CSV QA Expert

Overview
CSV QA Expert (Pharma/ Validation/ GAMP)
– role at
Manpower Singapore .
Location: Tuas
Industry: Pharmaceutical
Salary: Up to $8,000 depending on experience
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 the company’s quality requirements and the applicable cGMP regulations.
Providing quality oversight to the validation lifecycle (design to retirement) of computerized systems such as Computerized Information Systems (e.g., EMS, LIMS, MES, Data Historian), Process Control Systems (e.g., DCS, 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
Ensure all Computerized Systems Validation (CSV) lifecycle activities meet the company’s quality requirements and regulatory expectations.
Collaborate with IT, Automation, and Manufacturing to define and implement a risk-based validation strategy that confirms systems meet requirements and function reliably throughout their lifecycle.
Lead and provide quality oversight for establishing and maintaining the site’s CSV program in line with regulatory expectations, company standards, and industry practices.
Function as a key quality reviewer and approver of CSV lifecycle documents (e.g., URs/FSs, validation plans, risk assessments, protocols, reports).
Author CSV plans and procedures.
Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.
Drive continual improvement of the CSV program through periodic reviews.
Review, evaluate, and approve CSV-related non-conformities and changes; support investigations and corrective actions.
Ensure qualification/validation activities are completed, documentation is finished, non-conformities addressed, before GMP use release.
Provide support during regulatory inspections and site audits as quality oversight and CSV SME.
Collaborate with cross-functional teams to achieve GMP/operational readiness goals and ensure project deliverables are met on time.
Requirements
Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
7–10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and GAMP, plus industry best practices (ISO, ISPE, PDA) for CSV.
Working knowledge of quality risk management methods (FMEA, FTA) and their application to CSV.
Technical proficiency in risk- and science-based approaches to CSV.
Collaborative team player able to work with cross-functional teams to meet timelines.
Good communication skills to present validation strategies to site management and other functions.
Experience in greenfield/brownfield facility start-ups is advantageous.
Familiar with Digital 4.0 concepts and potential applications in Quality.
Ability to work independently with minimal supervision.
Experience ensuring Data Integrity in computerized systems.
Contact
Lim Pey Chyi
-

Recruitment Consultant (R )
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Staffing and Recruiting
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