Rajeshri Gajare
Site Formulation Qms Manager @Cipla
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WORK HISTORY
Site Formulation Qms Manager @Cipla
Corporate QA Manager – Laboratory ComplianceCipla Ltd.| Qidong, ChinaProvide corporate QA oversight for QC laboratory compliance, ensuring alignment with global QMS and regulatory requirements.Lead QMS implementation, audit readiness, and continuous improvement initiatives for the China site.Oversee OOS, OOT, deviations, investigations, and CAPA, ensuring robust root cause analysis and timely closure.Drive global CAPA deployment, self-inspections, and instrument performance reviews to mitigate audit risks.Govern analytical methods, SOPs, calibration, stability, and critical QC activities to maintain sustained compliance.Champion a culture of continuous audit readiness, documentation governance, and quality excellence
EDUCATION
St. Andrews School Vasco Goa
Bachelor of Science - BS
ABOUT RAJESHRI GAJARE
Pharmaceutical Quality & Compliance leader with 19+ years of experience across Quality Management Systems (QMS), Quality Control, Stability Studies, and Regulatory Compliance in a USFDA-regulated environment. Proven expertise in driving cGMP compliance, inspection readiness, audit management, and CAPA effectiveness for regulated markets.Currently working as Manager in Cipla Corporate office– Quality Control / QMS at a leading multinational pharmaceutical organization, with deep hands-on experience in USFDA inspections, 483 observation remediation, deviation management, OOS/OOT investigations, and quality risk management. Strong background in supporting regulatory audits, customer audits, and self-inspections, ensuring sustained compliance and data integrity.Brings extensive technical expertise in aerosols and inhalation products (MDI) and Nasals, registration and commercial stability studies, CMC support, and analytical data review. Known for simplifying SOPs, strengthening quality systems, and embedding a culture of continuous improvement and patient safety.A collaborative leader skilled in cross-functional engagement with QA, QC, ADL, MSTG, Manufacturing, and Regulatory Affairs teams to resolve complex quality issues and support successful product lifecycle management.Currently responsible for JV Operations – Cipla (QV) Qidong, China
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