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Quality Assurance Officer/Qualified Person - Dublin

Function Group: Quality/RA / QP

Organization

In the continuously changing work arena, this organisation is at the forefront. In a virtual setting they provide all services when it comes to the supply chain in pharmaceutical development and production. With clients all over the world they are looking for an ambitious and driven Quality Assurance Officer/QP to strengthen the team!

Function

In this quality assurance role you will be responsible for a wide array of responsibilities and tasks regarding your own product range (p.e. capsules, OSD, sterile products, creams). Main point of focus being the generation and maintenance of technical agreements with contract manufacturers (CMO’s) and customers. Additional responsibilities consist of non-conformance reviews and follow-up of corrective actions, preparation of external audit schedules and managing the audits execution and CAPA-plan. Complaint and deviation logging will also be one of your tasks. Regarding QMS documentation management: responsibilities such as SOP generation, update and review, including training will be in your workload. To complete this selection of responsibilities: QA support through NPI’s and preparation of all quality quarterly reports are something this organisation can rely on you for.

Besides the above tasks and responsibilities you, as QP, you will release of medicinal products where required

Requirements

The ideal candidate:

  • Has a minimum of three years of relevant experience in an EU GMP/GDP environment
  • Is a certified QP in Ireland
  • Holds a Master’s or Honour’s degree in a scientific area
  • Has a good knowledge of FDA requirements
  • Ideally has experience in a virtual environment and has knowledge of quality control in a lab setting
  • Is pragmatic, flexible and communicative, and has a hands-on approach
  • Loves to work on their own initiative and in project teams, this in a high pace, multi-cultural environment

Offer

Besides a competitive salary and secondary package the organisation offers good options for career progression (senior level, management level) and the opportunity to travel all over Europe and abroad!

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Martin van der Velden
Consultant Clinical Research & Medical Affairs

+31(0)23-7548660
+31(0)6-83656209
m.vandervelden@qtcrecruitment.com

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