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 new 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

📌 GM/DGM - QA (Bawal)
🏢 Getwell Pharmaceuticals
📍 Bawal