📢 Hiring: Quality Project Specialist 📢
🔬 Join a Biologics Pharma MNC
📍 Location: Tuas (Pick up islandwide)
⏳ Contract Duration:12 months
🕘 Working Hours: Monday – Friday, Office hour
💰 Salary: up to 7k (Based on experience)
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:
o User Requirements Specifications (URS)
o Functional Specifications
o Risk assessments
o IQ/OQ/PQ protocols and reports
o 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.
How to Apply: send your resume to: jocelynchan@recruitexpress.com.sg or telegram @jocelynchan ASAP!
Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820
