QC Stability Specialist

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.,

• 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.
  
  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!, 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
  
  We are a growing and ambitious specialist manufacturing business and with this comes opportunities for our people. At TP, we are going places. A career at TP 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 produce essential medicines for people across the UK and beyond. Together, we can get the job done., 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 - we reward our people for getting the job done.