Quality Specialist

3 weeks ago

Municipal District of Carlow, Ireland QCS Staffing Full time
Quality Specialist - Pharmaceuticals - Hybrid/Carlow, Ireland - 11-Months

With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a Quality Specialist to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.

Role Summary
  1. Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications.
  2. Be a document system expert; this will include document review, approval and document system workflow expedition.
  3. Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so.
  4. Documents will include SOPs, SWIs, training documents, and change controls.
  5. 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.
  6. 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.
  7. Support and lead Internal Quality audits of Engineering Dept.
  8. Assist in the management and/or assignment of Engineering training if required.
  9. Work collaboratively to drive a safe and compliant culture in Carlow.

Requirements
  1. A strong career history in pharma (ideally working in a clean utility and/or compliance environment) and familiarity with a highly regulated environment.
  2. Experience of working in a cross-functional environment.
  3. Knowledge of and experience in applying Six Sigma and Lean methodologies.
  4. Experience in Compliance systems such as IPI, SAP, etc. is a distinct advantage.
  5. Experience working within an Engineering environment in a regulated industry is a distinct advantage.
  6. Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical).

If this role is of interest to you, please apply now#J-18808-Ljbffr

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