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Quality Specialist

  1. Midlands (Ireland)
Carlow
  1. Contract
Competitive
  1. Compliance / Quality Assurance
34789
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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:
  • 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 SOP’s, SWI’s, training documents, and change controls.
  • Raise CAPA's 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).  

 
If this role is of interest to you, please apply now! 


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