GMP Compliance Officer

About the role

The GMP Compliance Officer ensures that all manufacturing activities adhere to current Good Manufacturing Practices (cGMP) and related regulatory requirements. This role supports the Mammalian and Drug Product Manufacturing Department by preparing, reviewing, and managing critical quality documents.

Key responsibilities

• Maintain cGMP compliance across facilities, documentation, training, reports and records during manufacturing operations.
• Prepare and review GMP documents such as risk assessment protocols, cleaning and process validation protocols, master formula records and batch manufacturing records.
• Handle change controls, deviations, CAPA, and investigation reports for mammalian manufacturing.
• Develop and review IQ, OQ, PQ and RQ documents for equipment qualification and participate in equipment/facility qualification and re‑qualification.
• Support GMP audits, facility readiness, and conduct quality‑based audits, investigations and root‑cause analyses.
• Coordinate with R&D, QA, QC, engineering, warehouse and other departments to ensure seamless interface.
• Manage electronic document control, computer software validation of computerized systems, and ensure personnel safety in coordination with the EHS team.

Required profile

• 3‑4 years of experience in GMP/compliance within a biopharmaceutical manufacturing environment.
• Master’s degree in Biotechnology or a related scientific field.

Required skills

• cGMP compliance and documentation
• Risk assessment and process validation
• Equipment qualification (IQ/OQ/PQ/RQ)
• Computer software validation
• Electronic document management systems

What we offer

• Opportunity to work in a regulated biopharma manufacturing setting.
• Collaborative environment with cross‑functional teams.
• Professional development in GMP and regulatory affairs.