 Well experienced in Pharmaceuticals in field of Quality Control / Quality Assurance, regulatory compliance, GxP (GLP, GMP, GDP, GAP, GMP,GAMP etc.,), Qualification, Validation, Verification of Analytical method and transfer (AMV/AMT), cleaning validation-CLV, stability studies etc.,  Well versed and handled audits multiple times… USFDA, WHO, MHRA, ANVISA, MCC, TGA, ISO- 9001 EU GMP etc., and various national/international customer audits Pfizer, SUN, DRL, CIPLA,STIRA,PRP etc.,  Well versed for Quality management systems QMS, QRM, CAPA, CC- Change control, deviation, OOS/OOT, OOC; audit compliance, commitment status updates, market complaints etc.  Experienced on 21 CFR part 11, EU GMP Annexure-11, GAMP 5.2, Electronic Signature ER, Electronic Record ES, software validation such as Empower2, 3, Lab solution, Totalchrom and other software’s of QC instruments, SAP, LIMS, Track wise, data integrity DI, ALCOA++ and its remediation, ISO 14001 and OSHAS 18001 etc.,  Well versed with Site Master File-SMF, Validation Master Plan-VMP, Water System, AHU, Technology transfer, Quality Managements system, MBR/BPR, APQRs, process validations, cleaning validations, Audits and inspections and its CAPA implementation and tracking etc.,  Strong analytical and problem solving skills, go getter, initiative, highly organized, has ability to work under pressure and drive projects.  Excellent interpersonal skills, has ability to resolve conflicts in amicable way.  Sensitive about business goals and budget matters.  Handled multiple Quality issues and implementation of corporate procedures at site.  Handled regulatory agency audits, have exposure of all pharmaceutical Quality domain expertise in multiple fields (i.e. Tablets, Capsules, Suspensions, Injections, (OSD & Sterile) etc.,) and API.  Technical skill and knowledge for all QC instruments; QC functions, different software’s in view of 21CFR; analytical, microbiological functions of sampling, analysis, releases, stability study, analytical method transfer, analytical method validation, instrument calibration, qualification, software validation, new lab setup etc. Experienced in executing and preparing Drug master file (CTD QC part). To find out the root cause for deviations from OOS and OOT procedures using Fish bone diagram, 5W1H, Failure Modes and Effect Analysis (FMEA) and Fault tree method (FTA).