Devendra Dubey Email & Phone Number

Technical Expertise:-Sound knowledge in preparation of SOP's, BMR, BPR, MFR, Quality Manual, Training Manual.Monitoring and review of qualification activities, review of DQ, IQ, OQ, and PQ of equipment and systems.Monitoring and review of Specification, Standard Testing Procedures & General Procedures.Maintain the quality systems such as; Change Control, Deviation Control, Out of Specification, Control of Non-conforming products, CAPA, Product Quality Reviews, Documentation control.Co-ordinate with Regulatory Affair to fulfill the documentation requirements for Dossier preparation, COPP,etc.Novice in preparation of Annual Product review, trend analysis of complete procedure.Monitoring the production activities and co-ordinate with production personnel to fulfill the documentation requirements.Review of Validation protocols & reports, monitoring of Process validation.Releasing of finished products to the market and review of BMR after completion of production as per specifications and pharmacopoeias.Novice of Handling of quality & non-quality customer complaints and Handling of return and rejected goods.Sound knowledge of ICH, GMP, GLP and cGMP practices.Novice in Multidisciplinary, Safety and efficacy Guidelines.Operating system 98, XP and MS-Office (Word, Excel & Power Point).

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  Pharma Professional

  Hollister Incorporated

  Jun 2013 - Present

  Quality Assurance

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  I.F.T.M. Moradabad

  Ph'Ceutical Chemistry