Description
IT CSV Consultant
My client has a requirement for an experienced IT CSV Consultant to join their project.
Duties:
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Responsible for validating, at a minimum new or changes to Automation systems (eg Delta V), Enterprise Systems (eg LIMS, CMMS, HPQC, Empower), Laboratory Equipment (eg TOC, UV-Vis, HPLC), Data Historian (OSI Pi).
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Coordinating and monitoring the validation phases and informing management of project progress.
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Assess systems to determine validation and data integrity requirements.
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Develops and executes all validation project deliverables. Capable of owning issues and driving them to resolution. Capable leading testing efforts for small to medium sized projects. Interacts directly with project teams.
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Generating Validation/SDLC documentation eg VRQ, SRA, VP, URS, FRS, IQ, OQ, PQ, DIA, RTM, VSR.
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Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines.
Qualification:
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BSc qualification (Degree) in a scientific, technical or engineering discipline
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5+ years of experience working with Computer Systems for pharmaceutical/Biotech manufacturing facilities.
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Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.
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Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
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Experience with HP Application Lifecycle Management (ALM) or equivalent software testing/requirement tools