Qc Stability Specialist - Paignton, United Kingdom - Torbay Pharmaceuticals

Torbay Pharmaceuticals

Verified Company

Paignton, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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

About Torbay Pharmaceuticals

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.

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

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 - we reward our people for getting the job done.

Benefits: