Biotechnology Jobs | Lupin Is Hiring Officer – GMP Compliance | Apply Now
Looking for biotechnology jobs in the pharmaceutical and biopharma industry? Lupin Limited has announced Officer jobs for GMP Compliance at its Pune Biotech facility. Candidates with a Master’s degree in Biotechnology and experience in GMP documentation, validation, manufacturing compliance, and regulatory processes can apply for this exciting Lupin career opportunity in the biotechnology manufacturing sector.
- Job Title: Officer – GMP Compliance
- Location: Pune Biotech, MH, IN
About the Company
Lupin Limited is one of India’s leading pharmaceutical and biotechnology companies with a strong global presence across multiple healthcare sectors. The company specializes in branded and generic formulations, biotechnology products, APIs, and complex pharmaceutical solutions. Lupin is recognized for its innovation-driven manufacturing facilities, global regulatory standards, and commitment to quality healthcare solutions.
Key Responsibilities
- 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 coordination with the 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 documents to GMP standards.
- To perform the Computer software validation of computerized systems (Existing and new).
Qualification
Masters in Biotechnology with 3-4 years of Work Experience
Skills Required
- Strong understanding of cGMP and biotech manufacturing
- Knowledge of validation and qualification processes
- Experience with CAPA, deviations, and investigations
- Documentation and audit management skills
- Regulatory compliance understanding
- Team coordination and communication skills
- Attention to detail and analytical thinking
Candidates seeking biotechnology jobs in pharmaceutical manufacturing and compliance should explore this Lupin career opportunity in Pune. With exposure to GMP operations, validation, regulatory compliance, and biotech manufacturing systems, this Officer jobs opening offers excellent career growth for biotechnology professionals aiming to work in the pharmaceutical and biopharma sectors.
