QA Manager (External Manufacturing)

Competitive
Permanent
Dublin North
07 Jul 2020
BBBH759998

A fantastic opportunity for Senior QA Specialist with CMO QA experience, to progress to management role in North Dublin

This a priority role, with interviews taking place virtually over the next two weeks

PERM | DUBLIN NORTH | VERY COMPETITVE SALARY & GREAT BENEFITS

THE ROLE
I am delighted to be partnering with a well established pharmaceutical company in North Dublin who are looking to hire a driven QA Manager to join their close-knit QA team, who will manage their CMOs, ensuring QA & QC standards are implemented and maintained across multiple sites. The ideal candidate for this role will have a strong demonstrated background across CMO management, excellent hands-on understanding of QA & QC regulations across cGMP environments. This role will have minimal travel involved. There are no direct reports in this role.

THE RESPONSIBILITIES

  • Implement and maintain QMS with CMOs
  • Utilise CAPAs to ensure all potential improvements are identified and tracked
  • Review and sign-off of master production, process validation, and cleaning validation documentation provided by CMOs.
  • Complete the disposition of APIs, raw materials, finished products, and components when necessary
  • Reduce, mitigate product risk and systems
  • Engage with continuous improvement methods, developing opportunities for enhancement of processes and systems

THE REQUIREMENTS

  • Level 8 Degree in Life Sciences, Chemistry or Biochemical Engineering, or another relevant field
  • 5 + years of relevant QA and/or QC experience in the pharmaceutical industry
  • Strong understanding and knowledge of cGMP guidelines and manufacturing operations
  • Previous experience in managing CMOs is highly sought after for this position
  • Demonstrated understanding of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Understanding the steps involved in the preparation for FDA and EMA inspections.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Kate Moriarty's picture
Consultant | Manufacturing, Automation, Process & Project Engineering Recruitment.
Cork 353 (0) 21 2300300 | kmoriarty@morganmckinley.com