Senior QA Specialist

About the role

We are looking for a Senior QA Specialist to lead compliance and quality initiatives for our biometric services and computer systems. The role combines hands‑on QA execution with audit leadership, risk management, and close collaboration across data management, biostatistics, software development, IT, and security teams.

Key responsibilities

• Conduct and host internal and vendor audits; review Trial Master File (TMF) for completeness and compliance.
• Track audit findings, deviations, and CAPAs; perform risk‑based audit planning and inspection readiness assessments.
• Develop, review, and maintain SOPs, policies, QMS documents, and ensure alignment with external regulations.
• Manage training curricula, monitor overdue training, and follow up with supervisors.
• Support computer system validation: review validation plans, test scripts, IQ/OQ/PQ protocols, and ensure re‑validation after changes.
• Ensure systems meet 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures.
• Coordinate audit‑readiness activities with IT and product teams, including system validation, log monitoring, and security scans.

Required profile

• Senior‑level experience in quality assurance within regulated environments.
• Strong knowledge of GxP, ICH‑GCP, and 21 CFR Part 11 regulations.
• Proven ability to lead audits, manage CAPA processes, and conduct risk‑based assessments.
• Excellent collaboration skills with cross‑functional technical and scientific teams.

Required skills

• GxP compliance
• ICH‑GCP knowledge
• 21 CFR Part 11 expertise
• Computer System Validation (IQ/OQ/PQ)
• Audit planning and execution
• CAPA management
• Trial Master File (TMF) review
• SOP and QMS documentation