Description
- Quality review and approval of validation master plans, strategies, risk assessments, protocols and reports, including commissioning reports supporting qualification.
- Provide Quality oversight for validation deviation investigations to resolve execution or result discrepancies. Participate in the resolution of deviations and corrective / preventive actions.
- Provide Quality review and assessment of associated change requests related to facilities, utilities and equipment changes.
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Approved validation reports adequate for external review and defendable to regulatory agencies during product review or site inspections -
Deviations escalated to senior QA management and product line impact determined
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