MES Testing & Validation at Teamware Solutions in Boston, MA
Teamware SolutionsBoston, MA
MES Testing and Validation
Should have worked on Life Science Computer System Validation, Risk Based Validation Approach Should have pharma manufacturing experience in computer systems Good experience in GxP Verification and Validation of Manufacturing Execution Systems Preference in ASTM e2500 validation strategy experience Should have experience in QbD validation strategy Should have experience in creating Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis Should be able to independently manage and deliver validation lifecycle of projects with minimum supervision Knowledge of 21 CFR Part 11 for Electronic Records and Electronic Signatures Good experience with SDLC and STLC Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems. Should have extensive exposure to Change Management process. Extensive Domain knowledge of Life Sciences Pharma domain. Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints. Good understanding of ITIL process. Involved in direct client interaction. Competent in conflict management and escalation handling.
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