Four Years of Experience in any occupation in developing PASX MES system specifications, including coordinating and executing all aspects of Change Specification, Functional Specification, Test scenarios and validation methods IQ, OQ, PQ, FAT, SAT, GAMP, Testing Protocols IQOQPQ, User Acceptance testing,br br Knowledge of Manufacturing Execution Systems MES, software project life cycle SDLC, GAP Analysis, pharmaceutical manufacturing, including FDA Regulation, ICH Guidelines, GAMP, EMEA and EPA requirements.
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