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Mandatory skills:

IT CSV IT QA / QA eCompliance Manager Experience with global patient safety, adverse event/product complaint reporting

Job Description:

This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client’s ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards.

Key Objectives/Deliverables:

Maintain Inspectional Readiness Ensure supported systems are validated Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans. Participate in self - inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood Ensure all Inspection Readiness materials are current and appropriate Deliver Projects, Programs, and Support Provide consulting and interpretation on client processes as related to the supported computer system Provide training to customer areas on CSV-related topics as needed Partner with Business, Business Quality, and IT customer areas to deliver business value Understand customer, company, and Quality priorities Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed Engage customers and QA management in appropriate discussions of risk management Ensure suppliers of computer systems or services meet quality expectations Escalate computer system quality issues to the appropriate persons Strive for and promote consistency within the CSQA Organization Streamline and Continuously Improve Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality Identify opportunity for streamlining and simplification and assist in developing improved solutions Understand external trends and potential ramifications for the supported IT area(s)