Role & responsibilities
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.
Robust 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 current or expanding sterile facilities will be preferred.
Excellent leadership, stakeholder management, communication, and team-building capabilities.
Preferred candidate profile
Regulatory Inspection Management & Audit Readiness
Global GMP Compliance
Sterility Assurance & Aseptic Operations
Quality Systems Excellence
Data Integrity & Quality Risk Management
Leadership & Team Development
Strategic Planning & Cross-functional Collaboration