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QC Stability Specialist

4 months ago

Paignton UK, Devon, United Kingdom Torbay Pharma Full time

Are you an experienced Stability Specialist looking to join a growing business? Do you have an eye for detail with excellent time management skills? If yes, then this could be the role for you


Torbay Pharmaceuticals are currently recruiting for an experienced Stability Specialist to join our growing team. This a key role for the business in which the successful candidate will have a genuine impact on our continued growth. Based on site at our Head Office in Paignton, you will liaise with all areas of the business to manage the study lifecycle from design to reporting for a range of sterile injectables to support new license applications for the UK and global markets.


About Torbay Pharmaceuticals


At TP we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner are now forging a new path in the private sector.


We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all of our people begin their working lives in pharma. Together we can make lives better.


What you can expect in a Stability Specialist role at TP:

Using your previous Stability testing experience in this role you will:


  • Liaising with other departments to ensure key deadlines are met within the study lifecycle
  • Designing and writing stability protocols for engineering and exhibit batches for new products for submission to the MHRA, HC and FDA.
  • Review and approval of raw data ensuring compliance to data integrity and method analysis.
  • Performing investigations and establishing root cause and implementing effective CAPA.Creating report of findings and presenting them to the client
  • First point of contact with internal and external customers for stability studies.


Requirements

  • Previous experience working within a Quality Control Laboratory
  • Knowledge and understanding of ICH Q1A (R2) Stability testing of new drug substances and drug products.
  • Analytical practical experience including but not limited to HPLC, UV, ICP-OES/MS, IC, Titrations.
  • Excellent knowledge of the Ph. Eur. and USP pharmacopeias.
  • Experience of generation of stability data packages for submission to the MHRA, HC and FDA.
  • Experience of Pharmaceutical Regulatory Agency GMP inspections
  • Direct external customer contact experience.
  • A pragmatic approach, able manage multiple projects and investigations.
  • Excellent communication skills


What we offer in return

At the heart of Torbay, we offer roles and career opportunities on your doorstep that you won’t find elsewhere. With defined career pathways, and the chance to move between roles and different departments, we support your career journey at every stage. TP is going places. International expansion means growth and new opportunities.


Our benefits set us apart. With 27 days holiday as standard – and the chance to buy more, group life assurance, pension - we reward our people for getting the job done.