My Client is one of Irelands largest pharmaceutical manufacturers. Based in Co Down, but with locations globally. A vacancy has arisen for a Senior GMP auditor within their Technical function.
- Conducting global external audits/inspections of current and potential API suppliers, Packaging suppliers, sub-contractors and service providers to assess the compliance of the organisations with their GMP obligation
- Review of all incoming audit reports from the clients auditors and third party contractors to ensure consistency of approach and observation categorisation
- Assessing the adequacy of CAPA responses from inspected organisations and assuring timely closure of same through regular review
- Conducting internal audits/inspections of departments, both scheduled and ad hoc, to assess the compliance of departments with GMP requirements. This will include, planning, conducting and reporting of inspections/audits with subsequent follow-up.
- Oversee the acceptable closure of CAPAs throughout the facilities and support structure
- Educated to graduate level and have experience and knowledge of GMP, Quality systems and processes within a pharmaceutical manufacturing environment
- At least three years pharmaceutical / quality auditing experience in internal and/or supplier auditing
- Experience of the planning and conduct of internal and external audits
- Experience of writing comprehensive audit reports