audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. more »
audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. more »
and working to support and track actions that are to be taken. Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory more »
and working to support and track actions that are to be taken. •Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. •Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections. more »
processes to ensure the product is compliant with regulatory requirements. Responsible for responding to customer quality requests, completion of customer quality questionnaires. Review any CAPAand non-conformances raised in the IMS and working with owners to ensure adequate root cause analysis has been conducted and any corrections or corrective … Quality Systems function within an ISO 9001 Management System, or similar Experienced internal auditor for ISO 9001 or similar Experience of investigating/reviewing CAPAand an understanding of root cause analysis tools Experienced in QA/QMS activities such as documentation control and change control processes. Experience of responding more »
