1 Year Contract Quality Assurance Project Specialist [WEST] #HZTT

Working Hours :
Mon to Fri Office Hours

Jobscope :
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

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, 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 :
- Min Diploma in any Science-related field
- Possess good interpersonal and communication skills

Interested candidates, kindly send a copy of your resume to: [email protected]

Jessica Fong Zhi Tong [R1879124]

Email Address: [email protected]

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