Serve as the Computer Systems Validation QA consultant lead to the ERMS project team. Perform Quality and compliance pre and post execution review of test scripts and defect reports to ensure compliance with clients SDLC and Computer Systems Validation procedures, CFR Part 11, 820, and Annex regulatory requirements. Provides guidance, interpretation, and assures compliance with Computer Systems Validation related regulations, quality manuals, company policies, and procedures. Demonstrate mastery of the company's policies for Computer Systems Validation.
Strong attention to detail, quality oriented. Develop validation strategy for GxP projects, including resource requirements and schedule. Lead and document computerized system risk assessments. Create and/or review validation documentation such as Validation Plan, URS, Functional Requirements, Design Documents, IQ/OQ/PQ and associated test scripts, and Validation Summary Packages.
Review computer system change requests and perform impact assessments. Identify exceptions associated with validation protocol execution and system maintenance and follow issue resolution procedures. CFR Part 11, 820, GxP