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processes for both IT and business functions in a GxP environment. Provide technical assistance as needed to analysts ... in change management and validation in a GxP environment. Working knowledge of Oracle databases. Knowledge of SDLC...
referred. ESSENTIAL Skills / Knowledge Required: * 5+ years of experience as an IT Project Manager * Pharmaceutical or Bio-Technology industry experience * Experience working in a GxP validation environment * Experience managing IT...
charters, budgets, process maps, and requirements in a GXP environment. In addition, this position will participate in the demand management process to assist the business in establishing business cases relating to new systems or existing...
industry experience * Experience working in a GxP validation environment * Experience managing IT projects in Biotech/Pharma involving CLINICAL processes and systems If you poses the background and would like to be considered please submit...
and facilities operate correctly and meet applicable GXP requirements. The qualification protocols need to meet internal company standards and customer expectations. Oversee and review Equipment and Facility qualification procedures and...
primary responsibility of the Sr. Audit Manager, GxP - IT is to execute GxP-IT (GMP, GCP, GLP; Information Technology ... The selected candidate will interface with the GxP-IT Quality/Compliance Management of Third Party suppliers/vendors, an...
4) Ensure that all procedures, specifications and other GxP documentation which impact on GLP/GCP and GPVP ... Lead interactions with regulatory authorities related to GxP quality or compliance issues Helpful TAGS: Biotechnology...
: As necessary, performs internal and vendor audits against GXP requirements, company policies & procedures, and contractual agreements; communicates observations to senior management via reports. o Documents any critical problems...
CFR 21, Part 11, HIPPA, SOX, Sedona Principles, GxP, etc) Experience with auditing principles, concepts and practices are required. Experience with Electronic Records and knowledge of ECM technology / software. Strong leadership,...
project charters budgets process maps and requirements in a GXP environment In addition this position will participate ... me at 856-761-0900 ext 120 to discuss in detail John Barry Scientific Search 101 East Gate Drive Cherry Hill NJ...
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