Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Monitors equipment/software processes for adherence to established procedures/regulatory compliance. Provides guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner.
We are an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled.