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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