Your role will be split between Batch Release and more general Quality Systems support. You will be paid a salary of up to £30,000, converted to an hourly rate.
A global, market leading pharmaceutical organisation with extensive operations in the UK, Europe and beyond. The company operates a combination of in-house and contracted out manufacturing as well as expanding through acquisition and therefore having legacy intergration and quality challenges. You will be based in an office in Hurley, Maidenhead, which hosts the QMS and co-ordinates the production and supply of Pharmaceuticals at other sites.
Following the acquisition of the site by a Big Pharma company a couple of years ago, the organisation is updating its Quality systems and processes on an ongoing basis and this will be an ideal opportunity to build on your QA experience. You will spend 70% of your time on Batch Release and 30% on Quality Systems Support (including interacting with the site QP). Your key responsibilities will include:
- Compile & review batch document sets for completeness & compliance to EU GMP, internal requirements and regulatory dossier submissions
- Resolve manufacturing, testing, packaging and supply chain issues to support batch disposition
- Complete all relevant documentation to support the QP in the release of drug products
- Assist the certifying QP in the release of the drug product where required within internal systems
- Complaint handling
- Deviations / exception reporting
- Change control
- Maintain supply agreements and perform other document control
- Quality metrics reporting
- Temperature excursion resolution, document control and retention systems
The successful candidate will have a degree (or similar) in a scientific discipline (chemistry, pharmacy, biology etc), combined with GMP QA experience gained in the Pharmaceutical industry, relating to manufacturing, distribution or control. A general understanding of Trackwise (or a similar electronic system) would be a significant advantage, as would previous experience of change control / change management. An understanding of biotechnology / biologics / sterile injectable manufacture and secondary / outsourced packaging activities would be a significant advantage but is not essential. Above all else, you will need a collaborative manner, strong communication skills and the ability to multitask. If you are selected, you will be paid an hourly rate which will work out equivalent to around £30,000 salary. This role is for 12 months initially (with a good chance of extension beyond this) and the experience you gain from this experience will be highly valuable.