The role: PE Global is currently recruiting for a Quality Engineer on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.
Description: They will work within a small team that will be mainly responsible for compliance aspects within the Engineering CoE team. This will include but not limited to the completion of investigations, generation and management of change controls and supporting the IFM Compliance and EHS Engineer as required.
Responsibilities: Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications. Be a document system expert; this will include document review, approval and document system workflow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, and change controls. Raise CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system. Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Support and lead Internal Quality audits of the Engineering Dept. Education and Experience: Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical). A strong career history in pharma (ideally working in clean utilities and/or compliance environment) and familiarity with a highly regulated environment. Experience of working in a cross-functional environment. Knowledge of and experience in applying Six Sigma and Lean methodologies. Experience in Compliance systems such as IPI, SAP etc. a distinct advantage. Experience working within an Engineering environment in a regulated industry a distinct advantage. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Interested candidates should submit an updated CV.
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