Experienced Quality professional with a demonstrated history of working in the pharmaceutical industry. Skilled in Pharmaceutics, Good Laboratory Practice (GLP), Validation, GMP, Investigation of Non-conformance, and Regulatory Affairs. Having an MBA Master's Degree from GJU S &T Hisar Haryana & Master's in Organic Chemistry from CCS University Meerut. Drive the team for All Time Audit Readiness, Compliance, and Leads Health Agency, Customer & Internal Audits. Design, Implementation, Review, and Monitoring of Quality Management Systems in the Pharmaceutical Industry. Handling Data Reliability Reviewing Activities and Reviewing the Electronic Data on labs software. Reviewing the AMV (Protocol & Report), Pilot Bio Batch Mfg. Record, Stability Protocols & Tech Pack. of R&D. Lead Auditor for Audit, Risk Evaluation & Compliance of Domestic and Overseas Vendors of Starting Materials, Intermediates, Packaging Materials, Excipient, APIs, CTL & Contract Mfg. Organization for OSD & Injectable. Determining training needs (TNI) ensuring appropriate training and qualification of Subordinates.  Calibration of Laboratory Instruments, Qualification of Mfg. Equipment and Validation of Methods / Process / System / Software / Cleaning procedure / CSV. Evaluation & Investigation of non-conformities like Market Complaints, Deviation, OOS, OOT, Non-Compliant Audit observation, and Incidents to identify the root cause, associated risks, and implementation of CAPA, also monitoring CAPA effectiveness to avoid recurrence. Execution QA & QC related Activities through SAP, BaaN, LIMS, Track wise, LES, Mini Tab, PLC, HMI, SCADA, LMS, etc. Analysis of Raw Material, PM, Stability, In-Process and Finished Products as per different pharmacopeia specifications on Various Laboratory Instruments & Reviewing of Analytical Docket. Maintaining Data Integrity, Quality Culture & Compliance Level & Risk Evaluation Process, Product & System. Facing Regulatory & Customer Audits and providing adequate & appropriate Compliance. Certified Trainer for conducting training on various cGMP Topics / GxPs at R&D and other sites. End to End Implementation of SAP in Quality Module & harmonization of QMS with all locations. Implementing, Evaluating, and Monitoring of Quality Systems of Contract Manufacturers (P2P & LL). Multi-disciplinary experience in formulating administrative strategies and effectively utilizing internal resources to facilitate operational excellence.