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
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.
- 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
- 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.
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