Biotechnology Job at Lupin | Officer – GMP Compliance | Apply Now
Securing an Officer – GMP Compliance position at Lupin Biotech offers a premier opportunity to join a global pharmaceutical leader at the forefront of biosimilar innovation. This Biotechnology Job in Pune is designed for professionals who are passionate about ensuring rigorous quality standards in mammalian and microbial manufacturing. As a key member of the Lupin team, you will be responsible for upholding cGMP excellence, managing complex documentation, and driving continuous improvement in a state-of-the-art facility. Embarking on a Lupin Career means working within a high-achieving environment where technical precision meets a commitment to life-changing healthcare solutions.
- Job Position: Officer – GMP Compliance
- Location: Pune Biotech, Maharashtra, India.
- Department: Mammalian and Drug Product Manufacturing.
- Category: Quality & Compliance / Manufacturing.
About the Company
Lupin is a leading global pharmaceutical powerhouse headquartered in Mumbai, India, dedicated to delivering high-quality, affordable medicines to patients across more than 100 countries. As one of the largest generic pharmaceutical companies globally, Lupin has established a significant footprint in the US, India, and emerging markets, with a specialized focus on cardiovascular, anti-diabetic, and respiratory therapies. A Lupin Career offers professionals an elite environment characterized by a strong culture of innovation and excellence, supported by 15 world-class manufacturing facilities and state-of-the-art R&D centers.
Key Responsibilities & Role Scope
In this Officer Job, you will be the guardian of GMP integrity across plant operations.
- Documentation Management: Prepare and review Master Formula Records (MFR), Batch Manufacturing Records (BMR), and Risk Assessment protocols for product changeovers.
- Quality Systems: Raise and manage Change Controls, Deviations, CAPA (Corrective and Preventive Actions), and detailed Investigation Reports for Mammalian Manufacturing.
- Validation & Qualification: Participate in and review IQ, OQ, PQ, and RQ documents for equipment qualification, alongside process and cleaning validation.
- Audit Readiness: Ensure facility preparedness for regulatory agency audits and conduct internal quality-based investigations and root cause analysis.
- Regulatory Interface: Coordinate with R&D, QC, and RA for technology transfer documents and assist in dossier and regulatory document writing.
- Digital Integrity: Perform computer software validation (CSV) for both existing and new computerized systems to ensure data integrity standards.
Eligibility & Requirements
Lupin is seeking technically proficient leaders with a solid background in biotechnology manufacturing.
- Education: Masters in Biotechnology is a mandatory requirement for this role.
- Experience: 3-4 years of relevant experience in GMP compliance within a biotech or pharmaceutical manufacturing environment.
- Technical Skills:
- In-depth knowledge of cGMP guidelines and regulatory standards.
- Hands-on experience in handling electronic document management systems.
- Understanding of Mammalian and Microbial product manufacturing workflows.
- Soft Skills: Excellent coordination skills with cross-functional teams (QA, QC, Engineering, EHS) and a detail-oriented approach to documentation and investigations.
Applying for the Officer – GMP Compliance role at Pune Biotech is a strategic step for anyone looking to excel in a high-impact Biotechnology Job. A Lupin Career provides the perfect platform to master the complexities of GMP standards while contributing to a globally respected manufacturing network. If you have the required Master’s degree and a passion for quality excellence in an Officer Job, ensure your application is submitted to join Lupin’s mission of transforming healthcare through precision and compliance.
