Audit and Supplier Qualification Specialist

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. 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: - Support, participate and host both Client and Regulatory audits. - Management of audit responses and ensure closure of actions within agreed timeframes. - On-going interaction with clients in relation to audits to ensure expectations and timelines are communicated in a proactive and timely manner - Management and co-ordinate all aspects on site Supplier Management Programme, including supplier audits, preparation of QTA’s and supplier qualification. - Ensure on-going compliance with customer, regulatory and internal requirements. - Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department. - Raise Deviations, Corrective Action Requests, and Non-Conformance...