Reeta Thakur
Pharmaceutical Quality Professional/Quality Assurance/Audit and Compliance/Quality Control/ Quality Management System/CSV/Green Belt Six sigma/ Expertise in regulatory audits (USFDA, EMA, ANVISA, RUSSIA/EAEU , WHO, RoW)
- Role
- Section Manager Qa (Qms & Aqa) at Panacea Biotec
- Location
- Chandigarh, CH, IN
- LinkedIn followers
- 500 followers
About Reeta Thakur
Pharmaceutical Quality professional with 15+ years of experience and Proven expertise in Quality Management System, Quality Control, Analytical QA, CSV, Auditing & Compliance, Data integrity compliance, AI-enabled compliance solutions & Training. Effectively used Lean Six Sigma (DMAIC) concept and Risk based approaches to achieve Laboratory and Operational excellence. Skilled in managing regulatory audits (USFDA, EMA, ANVISA, RUSSIA/EAEU, WHO, RoW) by aligning QC/QA operations with global regulatory expectations to ensure inspection readiness and a sustainable compliance culture.Core Competencies :• Regulatory Audit Management (USFDA, EMA, ANVISA, WHO, RUSSIA/EAEU, RoW)• Inspection Readiness & Audit Response Management• OOS/OOT Investigations and Root Cause Analysis• Quality Management System (CAPA, Deviation, Change Control, Risk Assessment)• Market Complaints and Recalls• Self Inspection/Internal Audit• Data Integrity & Audit Trail Review • Analytical Method Validation / Verification/Transfer • Stability Studies Management • Computer System Validation • Continuous Improvement (Lean Six Sigma, DMAIC)• Product Quality Review (PQR / APR)• AI-Enabled Quality Compliance (Automated Data Review)• Good Laboratory Practices (GLP, GxP) Compliance• Data Governance and Compliance (CSV Qualification, Backup, Data Storage, ER-ES )• Elemental and Nitrosamine Risk Assessments
Experience
Section Manager Qa (Qms & Aqa)
Jun 2023 — Present · Baddi, IN
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