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Urgent! CSV QA Expert (Pharma/ Validation/ GAMP) Job Opening In Singapore, Singapore – Now Hiring Manpower Singapore
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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Unlock Your CSV QA Potential: Insight & Career Growth Guide
Real-time CSV QA Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for CSV QA in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 826 jobs in Singapore and 634 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in CSV QA roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Manpower Singapore is currently hiring and seeking a CSV QA Expert (Pharma/ Validation/ GAMP) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: CSV QA Expert (Pharma/ Validation/ GAMP) Jobs Singapore.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Manpower Singapore adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a CSV QA Expert (Pharma/ Validation/ GAMP) Jobs Singapore varies, but the pay scale is rated "Standard" in Singapore. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for CSV QA Expert (Pharma/ Validation/ GAMP) typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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