- QA Officer
- Hurley, Maidenhead, Berkshire
- Up to £24,600 salary equivalent (paid as hourly rate)
- Exciting opportunity with a pioneering Pharmaceutical organisation
- New role due to recent acquisition by a Big Pharma company
- Compile and complete Annual Product Quality Reviews (PQRs)
- URGENT contract until end of 2017, with possibility of extension
A brand new role has arisen for a QA Officer, to join an organisation in Hurley, Maidenhead and assist in the completion of Annual Product Quality Reviews. This role is offered on a contract basis for around 5 months until the end of 2017, with possibility of extension beyond this. 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. If you have some GMP / GDP QA experience, with knowledge of Trackwise or a similar electronic system, and are looking for an engaging new challenge, this could be an excellent career opportunity. An understanding of biologics / sterile injectable manufacture would be a strong advantage. Apply ASAP!
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.
Your key responsibilities will include:
- Compile and review Annual Product Quality Review document sets for completeness and compliance to EU GMP and internal requirements
- Notify your line manager of any potential compliance issues identified during compilation of APQRs, such as; manufacturing, testing, packaging and supply chain issues.
- Complete all relevant documentation to support the QP in the release of drug products
- Assisting with metrics and data analysis of APQR activities.
- Extract and interpret information from the internal quality systems including deviations / exception reporting, change control, supply agreements, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the QA Manager.
- 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 (though Food and other GMP sectors will be considered too). 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 £24,600 salary. This role is until the end of the year and the experience you gain from this experience will be highly valuable.
QA Officer, Annual Product Quality Review, APQR, PQR, GMP, GDP, cGMP, Change Control, Change Management, Trackwise, Quality Assurance, QA Lead, Compliance, Quality Assurance Lead, Hurley, Maidenhead, Hampshire, Berkshire, South East
This is a contract position for 5 months initially