- QA Officer – Change Management
- Hurley, Maidenhead, Berkshire
- Up to £24,660 salary equivalent (paid as hourly rate)
- Exciting opportunity with a pioneering Pharmaceutical organisation
- New role due to recent acquisition by a Big Pharma company
- Integration of legacy change management system with a new global system
- URGENT contract for 6 months, with possibility of extension
Summary
A brand new role has arisen for a QA Officer, to join an organisation in Hurley, Maidenhead and assist in the 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!
The Company
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. 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.
The Role
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. Your key responsibilities will include:
- Review content and status of individual change controls and associated action items for both completeness and completion.
- Assist in the coordination and execution follow up with relevant functional groups and named individuals for the execution of change controls.
- Maintain change management packages and associated documentation repositories and tracking systems.
- Produce, maintain and present on associated existing change management system quality metrics.
- Coordinate transfer, as applicable of change management packages or action items to other responsible regions, such as Africa & Middle East (Afme).
- Migrate paper based records and systems which have not been closed in Q3/4 2017 to the new electronic Trackwise system, or equivalent.
- To work collaboratively with other system stakeholders (Regulatory, operations, quality, distribution, artwork control etc) to achieve a successful system remediation and transfer to the legacy business process.
Experience
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 £24,600 salary. This role is until the end of the year and the experience you gain from this experience will be highly valuable.
This is a contract position for 6 months initially