QA external manufacturing opportunity - Pharmaceutical - North Dublin
QA Manager - External Manufacturing
I am delighted to be working with a reputable North Dublin based Pharmaceutical company who are looking to strengthen their external external QA team.
The QA Manager (external manufacturing) will have QA responsibilities over 10 CMO's and 10 products. You will be part of a global team and will have the opportunity to work from home and flexibility where needed at the moment and beyond Covid. There is very little travel with this role at 15% and no auditing.
A stand alone role with no people management ensuring the highest level of quality operations for all CMO sites.
- Deploy and maintain GxP Quality Management Systems with CMOs and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times
- Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.
- Ensure that critical quality issues are reported to company management using the correct process
- Review and sign-off of master production, process validation and cleaning validation documentations provided by CMOs.
- Build good relationships with CMO's so the company is kept informed on process at all times.
The ideal candidate:
- Degree qualified
- If you are a Senior QA Specialist looking to take a step to management or you have 1 - 2 years in a similar role I would love to speak to you.
- Experience with CMO/ external quality and the parameters of working within this environment is essential
- Minimum of 5 years in pharmaceutical QA with at least 2 years in a CMO focused role
- Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. 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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