1 Year QA Project Specialist (West, Up to 8k) #HFT

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.

Requirements

• Degree in Science/Engineering or any other relevant discipline


For interested candidates, please submit your latest resume to [email protected]

Jacqueline Fong Hsin Ting (R21103226)

Recruit Express Pte Ltd

Company Reg. No. 199601303W

EA License Number: 99C4599