Work as GMP Compliance Trainee Officer at Lupin

Over the years, Lupin has grown and expanded into new areas and regions, manufacturing drugs that extend the promise of good health to communities across the globe. Beginning with two employees a peon-cum-packer and a part-time typist Lupin’s current global footprint spans 11 countries, across six continents. This journey has been made possible thanks to the vision and conviction of Dr. Desh Bandhu Gupta.

Post : Trainee Officer - GMP Compliance

Job Description
• Responsible for compliance with cGMP and related elements like facilities, documentation, trainings, reports, records during manufacturing operations. Preparation and Review of GMP documents related to Mammalian and Drug Product Manufacturing Department.
• To prepare and review documents like Risk Assessment protocols for product change over, Cleaning/Process Validation protocols, Master Formula Records, Batch Manufacturing Records. Review technology transfer documents for Mammalian and Microbial products with coordination with R&D, QC and RA.
• To raise and handle the documents like Change controls, deviations, CAPA, Investigation reports for Mammalian Manufacturing.
• To prepare and review IQ, OQ, PQ and RQ documents for equipment qualification in Mammalian Manufacturing Department.
• To participate in equipment and facility qualification, requalification, process and cleaning validation.

• To ensure GMP compliances during plant operations & during audit by regulatory agency. Facility preparedness for GMP audits. To conduct quality based audits, investigations and root cause analysis to promote continuous improvement.
• Involved in dossier and other regulatory document writing.
• Personnel safety compliance in co-ordination with EHS team.
• In-plant training to colleagues and contractual staff. Coordinator for departmental trainings.
• Assure the interface of manufacturing department with other departments like QA, QC, warehouse, R&D and engineering.
• Participate in investigations related to process, documents and incidents as and when required.
• Document Control: Log Book Issuance and Archival.
• To do the management of electronic document to GMP standards.
• To perform the Computer software validation of computerized systems (Existing and new).

Additional Job Responsibilities
• Investigations of incidents related to safety. Coordinator for EHS.
• Any responsibility advised by the superior from time to time.
• Coordination with Engineering, QA, QC, R&D, Purchase, and warehouse departments.
• To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site.

Additional Information
Experience : 3-4 years
Qualification : Masters in Biotechnology
Location : Pune Biotech
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GMP Compliance
End Date : 30th September 2026