Jayashree Ananda Pawar

Accomplished Quality Assurance Leader | 15 Years Excellence Expertise in Oral Solids, Liquids, & Ointments | USFDA, MHRA, TGA, & WHO Compliance. Strategic and proactive QA Leader with over 15 years of experience in the pharmaceutical industry. Proven track record of navigating complex global regulatory landscapes with an impeccable history of zero major or critical observations.

Expert in digitalizing QMS processes, spearheading validation policies (VMP/SMF), and fostering a culture of All Time Readiness (ATR). A logical problem-solver who thrives in high-pressure environments, specializing in harmonizing quality standards across multi-unit organizations to drive both compliance and operational efficiency.

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

Diploma - Regulatory Affairs Certification course for API and Formulation - IPM, Dombivli