Job Title: Quality Specialist - Pharmaceuticals
About the Role
We are seeking a Quality Specialist to support multiple capital projects taking place onsite in Leinster, Ireland. This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and our company's first stand-alone vaccine and biologics plant outside the US.
Key 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 Merck 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 Engineering Dept.
* Assist in the management and/or assignment of Engineering training if required.
* Work collaboratively to drive a safe and compliant culture in Carlow.
Requirements
* A strong career history in pharma (ideally working in a clean utility 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.
* Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical).