Computer System Validation III

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Computer System Validation responsibilities include:
: HP Quality Center experience required. : Creation of program-level computer systems validation documents for Trackwise (Validation Plans, Requirements, Reports) : Development of all associated documents (IQ, OQ, PQ) for GAMP-based validation of quality computer systems : Documentation of validation test results : Life Science manufacturing and systems regulations (21 CFR Part 11, GxP etc) : Understanding of Software Development Lifecycle Practices Technical (System Administration) responsibilities include: : Troubleshooting and resolving TrackWise application incidents and requests from a technical perspective. : Work/Service request technical assessment including TrackWise configuration solutions development. : Release Management, Change Management, Validation documentation compliance, Configuration Management, Capacity Management, Incident Management, Problem Management, Continuity Management and Application Security. : Technical and functional knowledge in Sparta System's TrackWise configuration and administration tools (Administrator and Coordinator). : Technical knowledge of Reports Development (Crystal Reporting preferred).

Skills/Experience Desired:
: Certification or experience with TrackWise configuration and deployment tools (Administrator, Coordinator) : Operational experience with Web-based applications in a Windows server environment : Reports development experience (Crystal preferred) : A minimum of 3 years of experience as a Validation Engineer working in an FDA regulated environment is required : Capable of working independently and within a team : Strong communication and documentation abilities and very strong Word and excel. : Excellent written and verbal communication skills and critical thinking abilities are a must The candidate must be a self-starter able to excel in a fast-paced environment with little supervision

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KELLY MITCHELL GROUP - 2 years ago - save job - block
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