Job Description
COMPUTER SYSTEM VALIDATION: 8-10 YEARS COMPUTER SYSTEMS VALIDATION / QA WITHIN FDA (GXP) REGULATED ENVIRONMENTS, INCLUDING 21 CFR PART 11 REGULATION AUTOMATED TESTING TOOLS VALIDATING AND QUALIFYING VARIOUS IT SYSTEMS USED IN LIFE SCIENCES ENVIRONMENT DEVELOPING FULL VALIDATION DOCUMENTATION AND TESTING PROTOCOLS (IQ/OQ/PQ/UAT) WITHIN THE VARIOUS SDLC PHASESHAVE EXCELLENT WRITING SKILLS. Good Communication skills. Be a self-starter and be motivated to provide a solid product quality and customer experience. Possess effective skills for analyzing, evaluating and troubleshooting for a specific scientific / technical discipline. Well-developed knowledge of pharmaceutical industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500). A Bachelor’s degree in Engineering, Management, Life Sciences, or other related technical field (or equivalent military training) with five or more years of experience in pharmaceutical or other regulated industry.
Qualifications null Additional Information
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