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Quality Lead Validation Engineer

VirtualVocations
Livonia, Michigan, United States
Full-time

A company is looking for a Quality Lead / Lead Validation Engineer to support the QISM group focused on IT Infrastructure and Clinical Operations.

Key Responsibilities : Provide oversight of computerized system implementation, maintenance, and retirement in GxP areasReview and approve system lifecycle documentation and deliverables for computerized systemsParticipate in regulatory inspection preparedness activities and identify areas of risk or non-complianceRequired Qualifications : Bachelor's degree and relevant GxP work experience8-10 years of experience performing validation activitiesExperience performing Infrastructure Qualification activitiesProficiency with FDA / MHRA regulations and computerized quality management systemsKnowledge of GAMP and Agile validation lifecycle methodologies

9 hours ago
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