- Lead QA, IPQA and QMS activities across the site.
- Manage deviations, CAPA, change control, OOS/OOT and risk management.
- Ensure inspection readiness and handle USFDA, MHRA, WHO, TGA and customer audits.
- Oversee batch review/release, documentation control and SOP compliance.
- Lead internal and vendor audits and drive continuous quality improvement.
- Ensure effective GMP training and quality culture across the organization.
- Partner with Production, QC, RA and R&D; on validation, technology transfer and scale-up activities.
Preferred candidate profile
We are looking for an experienced Head Quality Assurance to lead site QA operations and ensure compliance with global GMP and regulatory requirements.