QC Stability Coordinator

Job description

About Your New Employer

  • A globally known, award winning pharmaceutical company present in 190 countries.
  • They have 200 empolyees in their Dublin site and strive to improve the quality of life of millions through their products.

About Your New Job

  • The Stability Coordinator will manage stability programmes according to ICH for routine commercial products, Investigational Medicinal Products and non-routine requests.
  • Co-ordinate transfer of stability samples from approved third party manufacturing sites.
  • Ensure the effective day-to day running of the stability programmes. Organise the planning and scheduling of samples to be put on or pulled from stability. 
  • Review analytical stability documentation that has been generated within department for both commercial and none commercial products.
  • Critically review stability data and liaise with Technical Affairs, clients and corporate QA on any out of trend data. 
  • Amendment, review and approval of stability test methods and procedures. 
  • The Stability coordinator will perform laboratory investigations to resolve non-conforming data or out of trend data and liaising with clients on any non-conformances.
  • Review, generate and implement all stability protocols.
  • Compile formal stability reports including Time-Point and End of Study reports.
  • Ensuring that all stability equipment is calibrated and is maintained properly.
  • In the case of new stability equipment, maintaining and reviewing all equipment documentation
  • Development of a team of stability reviewers.

What Skills You Need

  • The Stability Coordinator will have a relevant 3rd level degree or above in Analytical Chemistry or related discipline
  • 3 years relevant laboratory experience in a cGMP environment.
  • Extensive experience with techniques such as HPLC/UPLC, Dissolution, GC.

What’s on Offer

  • Excellent basic salary on offer.
  • Annual Bonus, competitive pension plan and healthcare for yourself & dependents.
  • Brilliant work-life balance.
  • Flexitime.
  • Clear progression opportunities.

What’s Next

  • Apply now by clicking the “Apply Now" button or call me, Ben Byrne on 01-4744688.
  • Or if the job isn’t quite right but you are looking for something similar, please get in touch.

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