- M.Pharm / B.Pharm / M.Sc. with 20+ years of rich experience in Quality Assurance within sterile pharmaceutical manufacturing.
- Minimum 8 years in a senior leadership role handling site-wide QA operations for sterile injectable facilities.
- Extensive experience in sterile oncology products catering to regulated markets.
- Demonstrated expertise in successfully handling and hosting global regulatory inspections and customer audits, including USFDA, EMA, MHRA, ANVISA, WHO-GMP, PIC/S, and other international agencies.
- Proven track record in establishing and maintaining robust quality systems, sterility assurance programs, and inspection readiness culture.
- Solid exposure to aseptic processing, Annex 1 implementation, Contamination Control Strategy (CCS), data integrity,
and quality risk management.
- Experience in setting up and leading QA organizations for new or expanding sterile facilities will be preferred.
- Excellent leadership, stakeholder management, communication, and team-building capabilities.