Pharmaceutical Quality professional with enriched experience in Quality Management Systems with cGMP and regulatory compliance. Proven contributions in successful regulatory inspections (US, EU, MHRA, ANVISA, etc) and site quality remediation activities. Handling Quality Management Systems such as Deviation control and management, Change management, Quality risk management, CAPA management, OOS/OOT/OOE investigations and root cause analysis. Instrument calibration planning, Service level agreement with vendor.Global quality document review and assessment. Analytical method validation & transfer, Forced degradation studies- Project readiness. Stability studies, Process validation, Cleaning verification.Release of batch data, Pharmacopeial verification & compliance, Dossier review-Quality Module, Instrument Qualification & retirement, SOP updation, GMP Document handling.