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.
About the Company
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.
What is needed
- 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
- Clear progression opportunities
Apply now by clicking the “Apply Now" button or call me, Amy Morgan on +353 85 162 7272
Or if the job isn’t quite right but you are looking for something similar, please get in touch
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