• Responsible for GDP, cGMP, GLP, GHP, 5” S guideline’s.• Quality Leadership: Providing leadership and direction to quality control teams.• Overall monitoring in Quality Control department.• Audit and Compliance for all external, internal, Visitors, Vendor, Regulatory Audit’s & market complaint investigations lead.• Supplier Quality Management: Collaborating with suppliers and vendors to maintain the quality of materials and components used in the organization's products or services.• QMS Handing: OOS, OOT, Deviation, Incident, Investigation, CAPA, Change Control.• Planning, Analysis, Verification, Timely Release/Reject Materials: Raw Material, In-Process, Packing Material, Water, Finished Product, Stability Samples, New Vendor Material Samples & identify defects or deviations from quality standard.• Consumable Control: Reference Standard, Working Standard, Chemical, Reagent, Column, Glassware & Maintaining minimum stock level.• Analyst Qualification, Validation, Qualification, Method Development, Stability Protocol and Report, Instrument qualification, Calibration, Verification, Preventive Maintenance’s of Instrument & Equipment, Water validation, Passivation, Cleaning Validation, Line Clearance.• Responsible for preparation, approval and maintain of all master documents like Specification/STP, SOP, Formats, Checklist, Flow-Chart.• Acts as the primary source for training of Quality Control team.• R&D and R.A.– Coordinator: State FDA License related work under R.A & Validation and Tech Transfer under R&D.• Plant – Coordinator (Operational): Achieving highest standard of safe product clearance, adherence to SPC/STP/Protocol-BOM/BMR/BPR & maintain up-to-date documentation.• Continuous Improvement, identifying opportunities for process improvements, cost reductions, and operational efficiency while maintaining or enhancing product or service quality in Sampling, dispensing, manufacturing, filling, sealing, coding, packing to dispatch.

QMS, GLP, Quality & cGMP, GDP, DI, MSDS, GHP, GLS .  URS, IQ, OQ, PQ, Re-Q, PM, SOP Preparation, Yearly & Monthly planer.  Tech-Transfer, Validation- Protocol, Cleaning Method Validation. # CaliberLIMS® 3.7.1.E As Mater Creator Key Person, At Dahej site & Daman, Sarigam . Involved from IQ, PQ TrackWise , DMS, PLMS, Base E12 (ERP) documentation related, SAP Implementation Exposure. Primary, Reference /Working Standard & Impunity management.  # RM, IP, FP ,SS/HS ,PM , Cleaning Validation, Analysis to COA. Long term Water Validation & Environment Monitoring.  Expert in CALIBRATION of key Analytical Instruments, Equipment. Ultra-Micro, Micro , Semi- Micro, Precision Analytical Balance's  HPLC (Chromeleon): Calibration, Purging, Flushing, Sequence Preparation, Column saturation, Run. UV (UV Probe 2.50)  IR (Lab Solution 2.5)  Dissolution  Refracto & Polari meter (Rudolph)  TLC camag (vision CATS 3.1)  Dual zone (Daas 4.1)  KF & Auto titrator (Tiamo 2.5)  Friability testers  Disintegration time tester  Sieve shaker - Particle size distribution  IR Moisture Analyzer balance  pH & Conductivity meter  M.P./B.R. (EDC12)  Pycnometer  BD-TD tester Hardness tester Sonicator

 Raw Material /Finished Product Sampling & Analysis Wet lab Analysis & Titration , Hot Zone  Stability Study & Calibration , Standard Management  Water Analysis  preparation of Indicator/reagent and standardization of volumetric solution