Key Responsibilities:
Quality Oversight & Compliance
• Provide QA oversight for CSV activities in accordance with cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and company quality policies.
• Ensure project activities adhere to data integrity principles, including ALCOA+ requirements.
• Review and approve validation deliverables such as:
• User Requirements Specifications (URS)
• Functional Specifications
• Risk assessments
• IQ/OQ/PQ protocols and reports
• Test deviations, incidents, and change controls
Project Team Participation
• Serve as the QA representative on project teams for system upgrades, replacements, and new system implementations.
• Ensure project schedules account for appropriate QA activities, validation timelines, and regulatory requirements.
• Identify quality and compliance risks early and ensure timely escalation to the Department Manager.
Stakeholder Collaboration
• Work collaboratively with IT, OT, Validation, Engineering, and User departments to ensure systems are fit for intended use and compliant throughout the lifecycle.
• Act as a problem solver to help teams interpret requirements, mitigate compliance gaps, and maintain project momentum.
• Provide QA input during project meetings, design reviews, FAT/SAT, and qualification activities.
Documentation & Change Management
• Review and approve change controls related to computerized systems.
• Ensure documentation is complete, clear, accurate, and audit-ready.
• Support the Department Manager on major or high-risk decisions, validation strategies, and validation plans.
Job Requirements:
• Diploma or Bachelor’s degree in:
• Life Sciences
• Pharmaceutical Sciences
• Biotechnology
• Engineering
• Computer Science / IT
(related disciplines acceptable)
• Minimum 3–5 years experience in QA within a GMP environment
• Proven experience in Computer System Validation (CSV) from a QA oversight perspective
• Able to start within a short notice period
Interested candidates please forward your resume to anna.chen@recruitexpress.com.sg
Anna Chen jiaxin
CEI No: R25157621
Recruit Express Pte Ltd
EA License: 99C4599
