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Validation Lead - SDLC and CSV Job in Kalamazoo, MI United States

Position: Validation Lead - SDLC and CSV
Location: Kalamazoo, MI
Job Description:
•        Very good experience is SDLC and Computer Systems Validation (CSV)
•        Agile Methodology experience preferred
•        Supply chain experience preferred. Experience working with SAP ECC preferable.
•        Infrastructure Qualification experience
•        High level knowledge working with HPALM
•        Experience working in a cross functional system and within scrum teams.
•        Experience in Software validation and compliance activities in Pharma (GMP) environment
•        Experience in working with GxP applications
•        Experience in creation/maintenance & implementation of SOPs
•        Experience in the use of HP Quality Center and similar tools to manage software testing and requirements.
•        Worked in cGMP, 21 CFR Part11 and GAMP 5 environment
•        Hands on authoring/ review/ approval of computer system validation deliverables, inclusive of requirements gathering.  Functional specification, test/validation plans, protocols, test scripts / cases, traceability matrix and summaries.

Send resume to adelina@jobs-n-jobs.com or adelinajohn279@gmail.com
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