Corporate Quality Assurance Thane (CQA) - Hi media, Thane, Mumbai, Maharashtra - Thane, Mumbai, Maharashtra
(2026-02)
Oversee total quality operations for a centralized testing laboratory, managing cross-functional teams to ensure 100% accuracy in testing for multi-unit manufacturing sites while maintaining strict adherence to compendial (USP/BP/IP) standards.
- Expertly managing core QMS pillars including Change Control, Deviations, and CAPA, ensuring a closed-loop system for continuous improvement
- Leading both internal and external audits (including FDA audits for Analytical QC); ensuring 100% compliance with GMP and GLP standards
- Streamlining the end-to-end complaint lifecycle—from initial logging and investigation to tracking and final resolution across all locations
- Planning and monitoring stability studies for new and R&D-stage products, including final report approvals to ensure product shelf-life integrity
- Providing strategic guidance to Micro Laboratory functions and Analytical QC to maintain high testing standards
- Reviewing and approving Certificates of Analysis (COA) for batch releases, ensuring only compliant products reach the market
- Acting as the central liaison between CQA, Nashik, Ambarnath, and R&D teams to close compliance observations within stipulated timelines
- Successfully reducing human-error-related incidents through targeted GMP/GLP training and awareness programs
- Spearheading data collection and planning for Management Review Meetings (MRM) to provide leadership with actionable quality insights
- Evaluate technical and GMP agreements alongside vendor audit reports to ensure third-party compliance with internal quality standards
- Reduced deviations by 15%
- Closed 100% of audit observations within 30 days
- Training on QMS systems
- Planning and data collection of CQA MRM
Manager – Quality Assurance - Dortmund Laboratories, Dombivili, Mumbai, Maharashtra - Dombivili, Mumbai, Maharashtra
(2022-12 - 2026-01)
Spearheaded plant-wide compliance for a WHO-approved facility specializing in Oral Solids, Liquids, and Ointment dosage forms.
- Developed and implemented robust Quality Management Systems (QMS) and Standard Operating Procedures (SOPs) to foster a proactive quality culture
- Managed daily QA activities, including IPQA monitoring, team management, and the review/approval of Batch Manufacturing Records (BMR) and Batch Production Records (BPR)
- Held overall responsibility for the final release of batches for distribution and the approval of Certificates of Analysis (COA)
- Acted as the primary point of contact for local FDA and CDSCO; managed queries, new product license applications, and manufacturing license renewals
- Successfully facilitated applications for Certificates of Pharmaceutical Product (COPP) and Free Sale Certificates (FSC) for WHO-approved lines
- Led the preparation and submission of WHO Audit Application Files, ensuring all documentation met stringent regulatory standards
- Reviewed and updated Master BMRs, MBPRs, and Site Master Files (SMF) to align with current GMP requirements
- Formulated and implemented high-level policies, including the Validation Master Plan (VMP) and overarching Quality Assurance policies
- Approved product specifications and Technical Data Sheets (TDS), ensuring technical accuracy across all product lines
- Designed and executed the internal audit schedule covering Manufacturing, QC, Engineering, QA, and Warehouse departments
- Managed the end-to-end process validation for diverse dosage forms, including tablets, ointments, and oral liquids
- Oversaw the stability study lifecycle, from protocol approval and batch selection to the timely submission of data to the FDA and contract partners
- Partnered with Production, QC, and Stores to ensure seamless integration of quality
