GMP Compliance Officer

About the role

The GMP Compliance Officer ensures that all manufacturing activities adhere to current Good Manufacturing Practices (cGMP). You will support both mammalian and microbial production sites, maintaining high standards of documentation, training, and regulatory reporting.

Key responsibilities

• Monitor and enforce cGMP compliance across facilities, documentation, training, reports and records during manufacturing operations.
• Prepare, review and manage GMP documents for mammalian, microbial and drug product manufacturing departments.
• Raise, track and resolve change controls, deviations, CAPA and investigation reports for all manufacturing sites.
• Develop and review equipment qualification packages, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re‑Qualification (RQ) documents.

Required profile

• 2‑3 years of experience working in a GMP‑regulated manufacturing environment.
• Post‑graduation degree in Biotechnology or a B.Tech in Chemical Engineering.

Required skills

• cGMP compliance knowledge
• Change control and deviation management
• CAPA handling and investigation reporting
• Equipment qualification (IQ, OQ, PQ, RQ) documentation