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ABOUT THE ROLE

My client are one of the most desirable companies to work for in Dublin with a fantastic reputation globally, and we are currently looking for someone to join the team as a Quality Operations Manager on an initial 12 month contract basis. This could be a great opportunity for an experienced QA Specialist that is looking to take a step up, without the direct people management responsibilities as they would be managing the CMO.

This is a high volume, high value product portfolio and would suit someone that has had exposure to QA Operations, or perhaps come from a manufacturing site that is looking to work within External Manufacturing.

Responsibilities

  • Support and own CAPAs, Investigations and Deviations.
  • Provide quality and compliance support to the wider network including Supply Chain, Procurement, Technical Services, New Projects.
  • Provide quality support global functions like Regulatory Affairs/CMC and country based regulatory managers to support product renewals, regulatory filings, questions from regulatory agencies etc.
  • Support Quality Operations team in tech transfer projects and launch teams in relation to 3rd party activities.
  • Responsible for co-ordination of QA Metrics in regards to 3rd party performance.
  • Support in preparing Quality Agreements with the CMO and external partners.
  • Review of APR's from the CMO
  • Support on specific technical and quality projects

Requirements

  • BSc in a scientific discipline
  • Minimum 4 years experience in the pharmaceutical industry, ideally within QA Operations
  • Drug Product experience is highly desirable
  • Experience in interacting with CMO's
  • Experience and interaction with the regulatory agencies is desirable
  • Exposure to both External Manufacturing and on site QA would be highly desirable.
  • Motivated, ambitious, team player that is willing to learn and take on their own initiative when needed

Sounds interesting?

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SIMILAR ROLES

+44 203 475 84 31
68-70 S Lambeth Rd, Vauxhall London SW8 1RL