commercial QA activities associated with remote / virtual batch disposition.
This role is offered on a contract basis until the end of June 2021, with possibility of extension beyond this. If you have GMP QA experience, with knowledge of Batch Release Review experience, Trackwise or a similar electronic system, and are looking for an engaging new challenge, this will be an excellent career opportunity. Your focus will be on helping the company with their BREXIT preparations, including working with external 3rd parties.
Your role will be split between Batch Release and more general Quality Systems support. You will be paid a salary of up to £29,700, converted to an hourly rate (to be discussed on application).
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 integration and quality challenges. Your role will be aligned to the office in Hurley, Maidenhead, which hosts the QMS and co-ordinates the production and supply of Pharmaceuticals at other sites. At the present time, you will be able to work from home 100% of the time.
Your key responsibilities will include:
- Provide maintenance of quality systems primarily the creation of QP declarations and associated electronic system changes to support BREXIT preparations
- Supporting change management activities relating to BREXIT and site compliance activities
- Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP
- Support inspection readiness for BOH inspections and external vendor audits in relation to BREXIT changes
- Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to EU GMP standards
- To compile & review Product quality review sets for completeness & compliance to EU GMP, Hospira internal requirements and regulatory dossier submissions
- Project execution and support as required
The successful candidate will have a degree (or similar) in a scientific discipline, combined with some QA experience gained in the Pharmaceutical industry, with knowledge of Batch Release Review experience, Trackwise or a similar electronic system. An understanding of biotechnology / biologics / sterile injectable manufacture and secondary / outsourced packaging activities would be an advantage, but not essential. If selected, you will be paid an hourly rate which will work out equivalent to around £29,700 salary. This role is for 8 months initially (with a good chance of extension beyond this) and the experience you gain from this experience will be highly valuable.