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RR410

RR410

A highly motivated, project-oriented individual with over twenty years of Commissioning, Qualification, Verification and Validation experience in the Pharmaceutical, Biotechnology, Cosmetic and Medical Device industries. Computerized Systems Validation (CSV) Subject Matter Expert (SME). Experienced in Commissioning, Configuration, Qualification, Verification and Validation of pharmaceutical equipment, instruments & systems, including ERP, MES, CMMS, DCS, BMS, SCADA, LMS, LIMS, PLC, Utilities and HVAC in a cGMP environment utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology, ISPE Baseline Guides, ASTM E2500 Guide, and ICH Q9 and Q10, CFR Parts 820, 11 and Annex 13. Experienced in writing, executing, and reviewing validation master plans, project plans, vendor audits, user requirements specifications, risk assessments, functional specifications, detailed design specifications, factory acceptance tests, site acceptance tests, installation qualification protocols, operational qualification protocols, pre-functional checks, functional checks, final reports, standard operating procedures and work instructions. Project management skills include, liaison with stakeholders, manufacturers, vendors, contractors, quality, engineering, validation supervision of contractors, engineers and software developers, development and monitoring of project scope, budget, and schedule. Coordinated resolution of problems, deviations, exceptions and issues including Change Control. Supported project procurement expediting. Contributed to successful implementation and support of regulatory compliant control solutions including commissioning and startup, qualification and validation on many projects in USA & overseas.