Officer – Quality Assurance (QAMS & cGMP Compliance)
Location: IRF – Aurangabad, Maharashtra, India
Company: Lupin
Date Posted: February 9, 2026
Employment Type: Full-Time
Industry: Pharmaceutical Manufacturing | Quality Assurance | Regulatory Compliance
Lupin is hiring a Quality Assurance Officer for its IRF facility in Aurangabad. This role is responsible for supporting Quality Assurance Management Systems (QAMS), cGMP documentation, deviation handling, and regulatory compliance activities within a pharmaceutical manufacturing environment.
The position is ideal for professionals with hands-on experience in quality systems, SOP management, deviation investigations, batch record review, and validation documentation in regulated manufacturing facilities.
2 to 4 years of experience in Pharmaceutical Quality Assurance
Experience in:
QAMS documentation and compliance
Deviation, OOS, OOT, and CAPA management
cGMP documentation and regulatory standards
Batch record review and validation documentation
Experience in regulated manufacturing environments (USFDA, MHRA, EU GMP compliant plants) will be preferred.
Bachelor’s Degree in Pharmacy (B.Pharm)
Review and maintain quality system documents
Prepare and review Standard Operating Procedures (SOPs)
Issue, retrieve, and control SOPs, protocols, logbooks, and related documentation
Maintain all cGMP records as per regulatory requirements
Handle Quality Assurance Management System (QAMS) activities including:
Change Control
Out of Specification (OOS) investigations
Out of Trend (OOT) assessments
Deviations and laboratory incidents
Corrective and Preventive Actions (CAPA)
Review, assess, and close QAMS documentation within defined timelines
Review Batch Manufacturing Records (BMR)
Review Batch Packing Records (BPR)
Prepare and review Annual Product Quality Review (APQR) reports
Prepare and review Quality Risk Management (QRM) documentation
Review validation and qualification documents
Support compliance during internal and external audits
Manage control sample area as per SOP requirements
Ensure proper documentation, traceability, and archival processes
Strong understanding of cGMP and pharmaceutical quality systems
Knowledge of regulatory guidelines and documentation practices
Analytical approach toward deviation investigation and root cause analysis
Strong attention to detail and documentation accuracy
Effective communication and coordination skills
Ability to work in cross-functional manufacturing environments
Quality & Compliance Orientation
Documentation Excellence
Process Discipline
Analytical Thinking
Team Collaboration
Result Orientation
Work in a regulated pharmaceutical manufacturing facility
Gain exposure to advanced quality systems and compliance processes
Contribute to maintaining global regulatory standards
Build expertise in QAMS and cGMP operations
Lupin is committed to providing equal employment opportunities in recruitment, compensation, promotion, and training. All qualified candidates will be considered in accordance with applicable employment regulations.
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