Lupin has announced an opportunity for a Trainee Officer – GMP Compliance in Pune for biotechnology professionals interested in pharmaceutical manufacturing, cGMP compliance, validation and quality systems.

The position is based at Lupin Pune Biotech, Maharashtra and requires a Master’s degree in Biotechnology with 1–4 years of relevant work experience.

This Lupin GMP Compliance job involves supporting Mammalian and Drug Product Manufacturing operations through GMP documentation, equipment qualification, validation, deviation and CAPA management, audit readiness, computerized system validation and coordination with QA, QC, R&D and Engineering teams.

Candidates with experience in biotechnology or biopharmaceutical manufacturing environments and knowledge of cGMP, validation, GMP documentation and quality compliance may find this opportunity particularly relevant.

Lupin Trainee Officer GMP Compliance Job Overview

Key Responsibilities

As a Trainee Officer – GMP Compliance at Lupin, the selected candidate will support compliance and documentation activities associated with biotech manufacturing operations.

Major responsibilities include:

• Ensure compliance with current Good Manufacturing Practices (cGMP) across manufacturing facilities, documentation, training, reports and records.
• Prepare and review GMP documents associated with Mammalian and Drug Product Manufacturing.
• Prepare and review risk assessment protocols associated with product changeovers.
• Support preparation and review of Cleaning Validation and Process Validation protocols.
• Prepare and review Master Formula Records (MFRs) and Batch Manufacturing Records.
• Review technology transfer documentation for Mammalian and Microbial products in coordination with R&D, Quality Control and Regulatory Affairs.
• Raise, manage and document change controls, deviations, CAPAs and investigation reports.
• Prepare and review IQ, OQ, PQ and RQ documentation for equipment qualification.
• Participate in equipment and facility qualification and requalification activities.
• Support process validation and cleaning validation.
• Maintain GMP compliance during routine plant operations.
• Support facility preparedness for audits conducted by regulatory agencies.
• Participate in quality audits, investigations and root cause analysis (RCA) activities.
• Contribute to dossier preparation and other regulatory documentation.
• Coordinate personnel safety compliance activities with the EHS team.
• Conduct or coordinate in-plant training for employees and contractual personnel.
• Coordinate departmental training activities.
• Maintain effective interfaces between Manufacturing and departments including QA, QC, Warehouse, R&D and Engineering.
• Participate in investigations involving manufacturing processes, documentation and incidents.
• Handle document control activities including logbook issuance and archival.
• Manage electronic documents according to GMP requirements.
• Perform computer software validation / computerized system validation for existing and newly implemented computerized systems.
• Participate in investigations involving safety-related incidents.
• Coordinate with Engineering, QA, QC, R&D, Purchase and Warehouse departments.
• Follow applicable EHS management systems, policies, procedures, guidelines and legal requirements.

Qualification for Lupin GMP Compliance Job

Candidates applying for the Lupin Trainee Officer GMP Compliance vacancy should meet the education requirement stated by the employer:

Education: Master’s in Biotechnology

Candidates should carefully check the official Lupin job listing before applying to confirm that their specific degree and specialization satisfy the employer’s current eligibility criteria.

Experience Required

Lupin has specified:

Experience: 1–4 years

Relevant experience in areas such as biotech manufacturing, GMP compliance, quality systems, documentation, validation, qualification or related pharmaceutical/biopharmaceutical operations can be useful for this position.

This vacancy should therefore not be treated as a confirmed fresher opening, because the employer has explicitly requested 1–4 years of work experience.

Key Skills for GMP Compliance Role

Candidates may benefit from practical knowledge or experience in:

• Current Good Manufacturing Practices (cGMP)
• GMP documentation
• Mammalian manufacturing
• Biopharmaceutical manufacturing
• Drug product manufacturing
• Cleaning validation
• Process validation
• Equipment qualification
• IQ, OQ, PQ and RQ
• Deviations and investigations
• CAPA management
• Change control
• Root cause analysis
• Batch Manufacturing Records
• Master Formula Records
• Technology transfer documentation
• Regulatory documentation
• GMP audit readiness
• Document control
• Computerized System Validation (CSV)
• EHS compliance

Why This Role Can Be Valuable

The Lupin Trainee Officer GMP Compliance job in Pune provides exposure to several important areas of regulated biotechnology and pharmaceutical manufacturing.

The role covers GMP compliance, validation, equipment qualification, manufacturing documentation, deviations, CAPA, investigations, regulatory documentation, computerized system validation and audit preparedness.

It also involves cross-functional coordination with QA, QC, R&D, Regulatory Affairs, Engineering, Warehouse, Purchase and EHS, giving candidates broad exposure to operations within a regulated manufacturing environment.

Salary and Benefits

Lupin has not disclosed the salary package in the supplied job description.

For structured job-search information, an indicative market estimate for a biotechnology/GMP professional with approximately 1–4 years of experience in Pune could be around ₹3.5–6.5 lakh per annum.

Important: This is an independent market estimate for informational purposes and is not a salary figure announced or guaranteed by Lupin. Actual compensation may vary based on experience, existing CTC, internal salary structure, skills and selection outcome.

Employment benefits may be provided according to Lupin’s applicable company policies. Candidates should confirm compensation and benefits directly with the employer during the recruitment process.

How to Apply

Application Link