Quality Assurance Compliance Specialist

About the role

PSC Biotech is seeking a Quality Assurance Compliance Specialist to lead documentation management and regulatory compliance for manufacturing operations. Reporting to the Inspection Readiness Lead, you will ensure all quality and compliance documentation meets GMP/GDP standards and supports our top‑pharma clients.

Key responsibilities

• Author, draft, and maintain manufacturing operations documentation, specifications, and forms in collaboration with subject‑matter experts.
• Manage document updates, timelines, and approvals within the Controlled Document System.
• Organise and facilitate cross‑functional document round‑table meetings.
• Build and monitor Veeva QMS metrics for manufacturing operations.
• Coach and train colleagues on the documentation system, GDP/GMP queries, and Veeva paper binders.
• Generate reports and analyze trends from Veeva QMS, Doc Tracker, ASI/AIC, Logbook, and RFT metrics.
• Conduct logbook reviews, area self‑inspections, and schedule ASI activities.
• Support continuous compliance monitoring and facilitate internal and external inspections.

Required profile

• Strong understanding of GMP and GDP requirements in a manufacturing environment.
• Experience managing quality documentation and compliance metrics.
• Ability to train and mentor colleagues on compliance processes.
• Excellent organizational skills and attention to detail.

Required skills

• Veeva QMS
• Controlled Document System
• GMP/GDP knowledge
• Documentation management

What we offer

• Permanent contract with exposure to top pharmaceutical client sites.
• Opportunities for career development through in‑house training and mentorship.
• Diverse, multicultural work environment.