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 by managing documentation, training, and reporting to maintain regulatory compliance.

Key responsibilities

• Monitor and enforce cGMP requirements across facilities, documentation, trainings, reports, and records.
• Prepare, review, and maintain GMP documents for mammalian, microbial, and drug product manufacturing departments.
• Generate and manage change controls, deviation reports, CAPA actions, and investigation reports.
• Develop and review equipment qualification documents, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Requalification (RQ).

Required profile

• 2‑3 years of experience in GMP compliance or related quality roles.
• Post‑graduation in Biotechnology or a B.Tech in Chemical Engineering.

Required skills

• cGMP compliance
• Change Control
• Deviation Management
• CAPA (Corrective and Preventive Action)
• Investigation Reporting
• Equipment Qualification (IQ, OQ, PQ, RQ)