A brand new role for a QA Officer, to join an organisation in Hurley, Maidenhead and assist in the processing of commercial QA activities associated with remote / virtual batch disposition. This is part of a transition of an existing regional change management system into a bigger global system, following the acquisition of the site by a Big Pharma company. This role is offered on a contract basis for 6 months, with possibility of extension beyond this. If you have some QA experience, with knowledge of Trackwise or a similar electronic system, and are looking for an engaging new challenge, this will be an excellent career opportunity. Apply ASAP!
70% of your role will be Batch Release and 30% will be Quality Systems support. You will be paid a salary of £25,000, 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 recent acquisition of the site by a Big Pharma company, the organisation is updating its Quality systems and processes 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. 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, combined with some 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 £25,000 salary. This role is for 6 months initially (with a good chance of extension beyond this) and the experience you gain from this experience will be highly valuable.