Koerber Pharma Software, Inc. – $101,088.00/Year

H.10B. One Year Experience in coordinating and executing all aspects of validation including Validation Plans, User Requirement Specifications, Functional and Design Specifications, Testing Protocols IQOQPQ, User Acceptance testing, and Traceability matrices; implementing continuous improvement activities in in compliance with GAMP; cGxP, and FDA regulations cGMP, 21 CFR Part 210, 211, 11.br br Knowledge of Manufacturing Execution Systems MES, software project life cycle SDLC, GAP Analysis, enterprise application development and maintenance, system integration, pharmaceutical manufacturing, including FDA Regulation, ICH Guidelines, GAMP, EMEA and EPA requirements.