This role is offered on a contract basis for 6 months, with possibility of extension beyond this. If you have GMP Quality Assurance experience, with knowledge of Batch Release Review experience, working with Trackwise or a similar electronic system, and are looking for an engaging new challenge, this will be an excellent career opportunity.
Your role will be split between Batch Release and more general Quality Systems support. You will be paid an hourly rate of up to £20.38 / hour (paid via an umbrella company) which is roughly equivalent to a salary of £30,000.
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. 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. You will be able to work on a hybrid basis, with 2 days a week on site and 3 days from home.
The Role
Your key responsibilities will include:
- Assisting in maintenance of quality systems including deviations/ exception reporting, change control, supply agreements, document control, quality metrics reporting and training
- Completing scheduled records and quality system tasks in compliance with internal standards and EU GMP
- Compiling & reviewing Product Quality Review sets for completeness & compliance to EU GMP requirements and regulatory dossier submissions
- Supporting internal audits
- Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to EU GMP standards
- Participating in Quality Risk Management (QRM) assessments
- Assisting with completion of complex projects relating to continuous improvement
Experience
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, working with Trackwise or a similar electronic system. An understanding of 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 of up to £20.38/hour which will work out equivalent to around £29,700 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.