M. Pharm (Pharmaceutics), PGPMS (Welingkar Institute, Mumbai), Lean Six Sigma GB Certified with 12 years of experience in Pharmaceutical Quality Assurance/Management.- Execution and Review of Process Validation activities.- Execution and Review of Cleaning Validation activities.- Execution and review of Packaging Validation activities.- Execution and review of Continuous process Verification activities.- Involved in identification of product robustness using statistical approach. (Process capability analysis through Cpk/Ppk evaluations for CPPs and CQAs).- Involved in Investigations related to deviations, OOS/OOTs, quality events & market complaints.- Involved in Managing Product/Mock Recalls.- Involved in preparation/review of Quality Risk Management documents.- Involved in assessment/review of Deviations & Market complaints Trends, Root cause analysis & review of effectiveness of CAPAs.- Involved in review or approvals of Change control management system.- Involved in Third Party Manufacturing quality audits, health authority inspections & self-inspections at site.- Involved in preparation of Standard Operating Procedures (SOP) and Guidelines - Involved in preparation & review of Annual Product Quality Review documents.- Tracking of Quality management system data through Track Wise.- Involved in Operational excellence projects. (Product Scorecards, Lean technology, Efforts reduction).- Carrying out the Transport Validation activity.- Statistical Trend analysis of data through LIMS software/Minitab software.- Involved in monthly review of Quality management system relevant activities at Third Party and owned manufacturing sites(API/Solid Oral/Ointments/oral liquids/Dry powder/Syrups, Sterile Otic and Ophthalmic products etc)- Involved in Preparation & Review of Quality agreements (vendor/contract labs/contract manufacturing) followed by assessment & approval process - Involved in setting a new product control strategy with respect to identification of CPPs and CQAs.- Involved in Up-gradation of the Quality Guidance documents to make them in line with timely changing regulatory expectations