Navi Mumabi, India
Project Specialist
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About Me
Possess in depth experience of Planning, Preparation, Review, Approval & compliance of QMS & Technical Documentation i.e. VMP, URS, DS, UTM, TRS, FRS, DRS, FAT, SAT & Verification of Report, Summary, Conclusion & Recommendation for IQ, OQ, PQ documents.
I can manage development and implementation of entire Validation program for our clients.
I undertake complete validation tasks from basic to detailed on PLC validation & computerized system CSV based on GAMP 5 Guideline and commits to successful regulatory approval for its clients based on; Validation Master Plan VMP.
Early validation testing to ensure compliance with local health authorities, FDA and EMEA approval with no or minimal remarks.
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