Lupin Hiring For Trainee Officer – GMP Compliance

Lupin is hiring for the position of Trainee Officer – GMP Compliance at its Pune Biotech facility in Maharashtra. The role involves cGMP compliance, GMP documentation, validation activities, deviation management, CAPA, regulatory documentation, equipment qualification, and audit readiness for mammalian and drug product manufacturing operations.

Job Details

Position

Trainee Officer – GMP Compliance

The position focuses on maintaining Good Manufacturing Practice (GMP) standards across manufacturing operations, preparing and reviewing quality documentation, supporting validation activities, and ensuring facility readiness for regulatory audits.

Job Responsibilities

Selected candidates will be responsible for the following activities:

• Ensure compliance with current Good Manufacturing Practices (cGMP), including facilities, documentation, training, reports, and records during manufacturing operations.
• Prepare and review GMP documents for mammalian and drug product manufacturing.
• Prepare and review risk assessment protocols, cleaning and process validation protocols, Master Formula Records (MFRs), and Batch Manufacturing Records (BMRs).
• Review technology transfer documents for mammalian and microbial products in coordination with R&D, Quality Control (QC), and Regulatory Affairs (RA).
• Raise and manage change controls, deviations, Corrective and Preventive Actions (CAPA), and investigation reports for mammalian manufacturing.
• Prepare and review Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Requalification (RQ) documents for equipment.
• Participate in equipment and facility qualification, requalification, process validation, and cleaning validation.
• Maintain GMP compliance during plant operations and prepare facilities for regulatory audits.
• Conduct quality-based audits, investigations, and root cause analysis to support continuous improvement.
• Contribute to regulatory dossier preparation and other regulatory documentation.
• Coordinate personnel safety compliance with the Environment, Health and Safety (EHS) team.
• Conduct in-plant training for colleagues and contractual staff and coordinate departmental training activities.
• Coordinate with QA, QC, warehouse, R&D, engineering, purchase, and other departments.
• Manage logbook issuance, archival, and electronic document control according to GMP standards.
• Perform computer software validation for existing and new computerized systems.
• Investigate safety-related incidents and coordinate EHS activities.
• Follow applicable EHS management systems, procedures, guidelines, policies, and legal requirements.

Eligibility and Qualifications

Candidates applying for the Trainee Officer – GMP Compliance position should meet the following requirements:

• Educational Qualification: Master’s in Biotechnology.
• Work Experience: 3–5 years of experience.

Required Skills and Technical Knowledge

Based on the responsibilities outlined in the job description, the role involves working with:

• Current Good Manufacturing Practices (cGMP).
• GMP documentation and electronic document control.
• Deviation management, change controls, CAPA, and investigations.
• Risk assessment and root cause analysis.
• Process validation and cleaning validation.
• Equipment qualification, including IQ, OQ, PQ, and RQ.
• Master Formula Records and Batch Manufacturing Records.
• Technology transfer documentation.
• Regulatory documentation and audit readiness.
• Computerized system validation.
• EHS compliance and cross-functional coordination.

Walk-in Interview / Application Details

The job description provides the position, location, experience requirements, qualification, and posting date. No walk-in schedule or application instructions are included in the supplied details.