Sr. Validation Analyst PA or NJ Paragon Solutions, Inc. -
Plymouth Meeting, PA
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Paragon is looking for a Sr. Validation Analyst Lead to contribute to our life science organization. The Sr. Validation Analyst will be responsible for leading the strategy discussions for validation, development of all required SDLC deliverables and reports. Activities include participation in requirements gathering workshops to ensure testable requirements are gathered, preparation and facilitation of workshops, development of migration plan, and support the Technical team as needed. The candidate must have experience in the pharmaceutical industry and experience in computer system validation. Knowledge and experience working with GMPs protocols is preferred
Required Technical Skills:
Experience developing Validation Plan and directing overall validation strategy
In depth experience working in a Pharmaceutical SDLC processes
Experience writing all SDLC document (IQ, OQ, PQ and SDLC Documentation)
Strong GMP or GXP tools experience. MS Project Experience
Assist in development of migration strategy and test approach
Managing the execution of Validation Deliverables & UAT testing, Development of Validation Reports
Manages tracking test deviations
Directs the resolution of deviations and failures
Strong understanding of 21 CFR Part 11
Experience with Documentum, DCM EDMS Records Manager products
If you are interested, please send your resume to mlipari@consultparagon.com
Monster - 9 months ago
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