Labcorp Looking for Validation Proj Lead, Regional at Mumbai Full Time

Minimum Bachelor’s degree in engineering or scientific discipline (Pharmacy/biologics, Computer Science & Engineering, Instrumentation preferred) – Minimum 4-6 years relevant experience in Computer Systems validation and Instrument validation – Knowledge of 21CFRPart 11/ EU Annex 11/ OECD 17/MHRA Data Integrity Guidance/ OECD 22/ALCOA + principles – Must be well versed with SDLC methodology – Must have thorough knowledge of the application of GAMP5 guidelines – Must be knowledgeable about risk-based validation and have the ability to complete risk assessments using FMEA analysis – Excellent written and verbal communication skills in English – Must have working knowledge of MS Word and Excel – Knowledge of LIMS validation and Controlled Spreadsheets validation a definite advantage

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