Suraj Ghodekar
Manager @Tata Consultancy Services
Pune Division, MH, IN
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Mar 2025 — Present
Manager @Tata Consultancy Services
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Maharashtra, IN
US Site, Qualification and Validation, LS Domain, CSV, 21 CFR Part 11, US Regulations, Data Integrity, cGMP, GAMP, Kneat (eVal), Veeva vault,
EDUCATION
2007 — 2011
VJSM's Vishal Institute of Pharmaceutical Education & Research, Ale
Bachelor's degree, Pharmacy
2006 — 2007
Dnyanmandir High School and Junior College, Ale
HSC, SCIENCE
2004 — 2005
Dnyanmandir High School and Junior College, Ale
SSC, Science
SKILLS
Life SciencesPharmaceuticsU.s. Food and Drug Administration (Fda)Quality AssuranceValidationArea ValidationCleaning ValidationProcess Validation Protocol & Report Reparation and Execution ThereofQualification Protocol and Report PreparationBiotechnologyIpqaQuality SystemProcess ValidationArea QualificationStandard Operating Procedure (Sop)Pharmaceutical IndustrySopBmr ReviewingGmpHold Time StudyBmr Preparation
ABOUT SURAJ GHODEKAR
USFDA and EU Experienced and dedicated CSV, CQV, QA and QMS with several years of experience. Development of Validation plans and strategies and deliverables. Identifying efficiencies and problem areas within data streams, while communicating needs for projects.
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