Quality Assurance Project Specialist WEST #HZTT

Working Hours

Mon to Fri Office Hours

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

• 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.

• 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.

• 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.

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

Interested candidates, kindly send a copy of your resume to: h