R&D Quality Assurance Manager
Maternity Cover Contract
Our client is a multi-speciality healthcare company focused on discovering, developing and commercialising innovative products for the Eye Care, Neuromodulator, Skin Care and other speciality markets that enable people to live life to its greatest potential. In partnership with the medical community, they bring scientific excellence and rigour to deliver leading products that improve patient outcomes.
You will be joining a centre of excellence in the drug research and development space, featuring state of the art laboratories working on innovative treatments across a range of therapies.
This is an exciting opportunity for someone with GMP experience from a pharmaceutical Quality Assurance background to contribute their skills to exciting gene therapy and biologics projects.
Quality Systems Manager Key Responsibilities:
* Manage the validation system for each piece of equipment and complete documentation
* Liaise with system owner, validation and QA to ensure each required document is written correctly
* oversee the batch release process
* Feedback issues work closely with vendor qualification protocols
* Manage data integrity compliance across the site
* Ensure all validation data related to a validation exercise is properly collated
* Review and approve Quality documentation relating to manufacturing, testing and release of materials to be used in pre-clinical or clinical trials
The ideal candidate will have/be:
* Must have Quality Assurance experience from a pharmaceutical background
* Must have GMP background
* Ideally, experience within research and development or CMC
* Bachelors degree in science or engineering
* Proficiency with quality systems and IT systems, ideally Trackwise
* Biologics or genetic experience would be highly desirable
Apply now via this website or contact Rowena Deswert in the Bath office
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.