PHARMAFull-time
Trainee Quality Officer - GMP Compliance
By Admin · Quality Assurance & Quality Control
PUNE (IN)ONSITEPOSTED: 9/1/2026
PHARMAFull-time
HIRING ORGANIZATIONLUPINPharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Job Overview
Trainee Officer role focused on GMP Compliance within the manufacturing environment at Lupin's Pune Biotech facility.
Responsible for supporting compliance with current Good Manufacturing Practices and associated quality systems during manufacturing operations.
Supports GMP documentation, manufacturing documentation review, qualification, validation, investigations, audit readiness, training and cross-functional quality coordination.
The role has specific involvement with Mammalian Manufacturing and Drug Product Manufacturing activities.
Requires coordination with multiple functions including QA, QC, R&D, Engineering, Warehouse, Purchase and EHS.
The role also supports regulatory documentation, computerized system validation and electronic document management according to GMP standards.
cGMP Compliance & Manufacturing Quality
Ensure compliance with cGMP requirements and related quality elements during manufacturing operations.
Support GMP compliance relating to manufacturing facilities, documentation, employee training, reports and records.
Monitor and support adherence to applicable GMP requirements during plant operations.
Ensure manufacturing activities maintain required quality and compliance standards.
Support facility preparedness for regulatory and GMP audits.
Participate in quality-based audits and compliance activities.
Promote continuous improvement through quality investigations and root cause analysis.
Support implementation of improvements arising from audits, investigations and quality findings.
GMP Documentation Management
Prepare GMP documents related to Mammalian Manufacturing.
Prepare GMP documents related to Drug Product Manufacturing.
Review manufacturing and GMP documentation for completeness and compliance.
Prepare and review Risk Assessment protocols for product changeover activities.
Prepare and review Cleaning Validation protocols.
Prepare and review Process Validation protocols.
Prepare and review Master Formula Records.
Prepare and review Batch Manufacturing Records.
Ensure documents are prepared, reviewed and maintained according to applicable GMP requirements.
Support document control activities including Log Book issuance and archival.
Manage electronic documents according to GMP standards.
Technology Transfer & Product Support
Review technology transfer documentation for Mammalian products.
Review technology transfer documentation for Microbial products.
Coordinate technology transfer documentation and activities with R&D.
Coordinate with QC and Regulatory Affairs for relevant technology transfer requirements.
Support effective communication between manufacturing and supporting functions during product and process transfer activities.
Change Control, Deviations & CAPA
Raise Change Controls related to manufacturing activities.
Support management and handling of Change Control documentation.
Raise and manage deviation documentation.
Participate in investigation and management of manufacturing deviations.
Support Corrective and Preventive Action activities.
Prepare and manage investigation reports.
Ensure deviations, changes, investigations and CAPA activities are documented and managed according to applicable GMP procedures.
Participate in investigations related to processes, documentation and manufacturing incidents when required.
Equipment Qualification
Prepare and review Installation Qualification documentation.
Prepare and review Operational Qualification documentation.
Prepare and review Performance Qualification documentation.
Prepare and review RQ documents for equipment qualification activities.
Support equipment qualification activities within the Mammalian Manufacturing Department.
Participate in equipment requalification activities where required.
Ensure qualification documentation meets applicable GMP and quality requirements.
Process & Cleaning Validation
Participate in process validation activities.
Participate in cleaning validation activities.
Support preparation and review of validation protocols and associated documentation.
Participate in facility qualification and requalification.
Support validation activities required to demonstrate controlled and compliant manufacturing processes.
Contribute to maintaining validation status for relevant equipment, processes and facilities.
Audits, Investigations & Continuous Improvement
Support GMP compliance during plant operations.
Participate in regulatory agency audits.
Help maintain facility preparedness for GMP inspections and audits.
Conduct or participate in quality-based audits.
Participate in investigations associated with quality and compliance issues.
Support root cause analysis for identified process, document and operational issues.
Contribute to continuous improvement through investigation findings and quality observations.
Participate in process, documentation and incident investigations as required.
Regulatory & Dossier Documentation
Support dossier writing activities.
Participate in preparation of other regulatory documentation.
Coordinate with Regulatory Affairs where required.
Support accurate preparation and review of documents required for regulatory and quality purposes.
Electronic Systems & Computer Software Validation
Manage electronic documentation in accordance with GMP standards.
Support maintenance and control of electronic GMP documents.
Perform computer software validation for computerized systems.
Support validation of both existing computerized systems and new computerized systems.
Ensure computerized systems supporting GMP operations meet applicable validation requirements.
Training & Knowledge Management
Conduct in-plant training for colleagues.
Provide or coordinate training for contractual staff.
Act as a departmental training coordinator.
Support maintenance of required GMP training activities.
Coordinate training activities required for compliance and manufacturing operations.
Help ensure personnel understand relevant GMP procedures and operational requirements.
Cross-Functional Coordination
Assure effective coordination between the Manufacturing Department and Quality Assurance.
Coordinate with Quality Control.
Work with Warehouse teams.
Coordinate with Research and Development.
Collaborate with Engineering.
Coordinate with Purchase functions where required.
Support effective communication across departments involved in manufacturing and GMP compliance.
Participate in cross-functional activities involving process, equipment, quality and regulatory requirements.
EHS & Personnel Safety
Support personnel safety compliance in coordination with the EHS team.
Coordinate EHS-related activities where assigned.
Participate in investigations involving safety-related incidents.
Support compliance with current and future EHS management systems.
Follow applicable EHS procedures, guidelines, policies and practices.
Comply with site-level EHS requirements and applicable legal compliance obligations.
Coordinate with relevant departments to maintain safe manufacturing operations.
Additional Responsibilities
Perform additional responsibilities assigned by the reporting superior from time to time.
Support Engineering, QA, QC, R&D, Purchase and Warehouse coordination activities.
Take part in safety incident investigations when assigned.
Maintain compliance with site procedures and applicable legal requirements.
The listed responsibilities are not exhaustive and additional duties may be assigned.
In the absence of the role holder, responsibilities may be performed by competent and trained personnel from the team.
Education Requirements
Master's degree in Biotechnology required.
Experience Requirements
Requires approximately 3-4 years of relevant work experience.
Relevant experience in GMP compliance, biotechnology manufacturing, quality assurance, validation or related pharmaceutical and biopharmaceutical operations would be highly relevant.
Work Environment
Onsite position at the Pune Biotech facility in Maharashtra, India.
Works within a regulated biotechnology manufacturing environment.
Requires close interaction with manufacturing, quality, engineering, research and development, warehouse and EHS teams.
REQUIRED VERIFIED SKILLS
cGMP Compliance
GMP Documentation
Mammalian Manufacturing
Drug Product Manufacturing
Risk Assessment
Product Changeover
Cleaning Validation
Process Validation
Master Formula Records
Batch Manufacturing Records
Technology Transfer
Change Control
Deviation Management
CAPA
Investigation Reports
Root Cause Analysis
IQ
OQ
PQ
Equipment Qualification
Facility Qualification
Requalification
Process Qualification
Cleaning Qualification
GMP Audits
Regulatory Inspection Readiness
Regulatory Documentation
Dossier Writing
Document Control
Log Book Issuance
Archival
Electronic Document Management
Computerized System Validation
Software Validation
Quality Assurance Coordination
Quality Control Coordination
Manufacturing Compliance
EHS Compliance
Safety Incident Investigation
Microsoft Office and Digital Documentation Systems
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range or compensation information is provided in the supplied job description. Compensation for a Trainee Officer-level GMP Compliance role with 3-4 years of relevant experience may depend on Lupin's internal salary structure, biotechnology manufacturing experience, GMP expertise, validation knowledge and current market conditions in Pune. Candidates should clarify the fixed salary, annual performance incentives, statutory benefits, insurance, leave benefits, shift-related allowances where applicable, training opportunities and long-term career development benefits during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
Lupin is actively hiring for this position.
INDUSTRY: Pharmaceuticals
EXPECTED CAREER ROADMAP
This role provides a strong career pathway in pharmaceutical and biotechnology Quality Assurance, GMP Compliance and manufacturing quality systems. Experience gained in cGMP compliance, validation, qualification, change control, deviation management, CAPA, investigations and audit readiness can support progression into Officer or Senior Officer roles in QA and GMP Compliance, followed by opportunities such as Executive, Senior Executive, Quality Assurance Manager or Validation Specialist. Exposure to Mammalian Manufacturing, Drug Product Manufacturing and biotechnology operations can also create opportunities in biopharmaceutical quality, technology transfer, validation, computerized system validation and regulatory compliance. Developing expertise in regulatory inspections, root cause analysis and quality systems can support long-term progression toward QA leadership, GMP auditing, compliance management and global quality operations.
APPLICATION ADVISORY
Emphasize your Master's degree in Biotechnology and clearly state your 3-4 years of relevant experience. Highlight practical experience with cGMP compliance, GMP documentation, deviations, CAPA, change controls, investigations and root cause analysis. Include specific examples of preparing or reviewing Batch Manufacturing Records, Master Formula Records, validation protocols and qualification documents. Demonstrate knowledge of IQ, OQ and PQ, process validation, cleaning validation and equipment qualification. If you have experience in Mammalian Manufacturing, biopharmaceutical manufacturing or technology transfer, place this prominently on your resume. Prepare for interviews by reviewing cGMP fundamentals, data integrity, deviation investigation workflows, CAPA effectiveness, risk assessment, audit preparedness and computerized system validation principles. Be ready with practical examples showing how you coordinated with QA, QC, Engineering and R&D to resolve quality or manufacturing issues.
RECOMMENDED TRAINING
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