QA Specialist - Audit

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. We are looking for a QA Specialist - Audit to join our team in Stamullen. Summary of Role: The role is to implement and execute tasks relating to GMP auditing and supplier qualification in the PCI sites in Ireland. Key Responsibilities: - Provide support during the preparation of client audits and regulatory inspections. - Support all aspects of the site Supplier Management Programme, including supplier audits, risk assessments, preparation of QTA’s and supplier qualification. - Co-ordinate backroom support activities for all major client audits and regulatory inspections. - Track all audit responses and action items to ensure they are completed within agreed timeframes. - Maintain, update and track the internal and supplier audit schedules including audit completion and response receipt. - Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required i...