QA Specialist Biologics

24 Jul 2019
21 Aug 2019
Contract Type
Full Time
Graeme Pallas at CK Group is recruiting for a QA Specialist to join a leading biopharmaceutical organisation in their Biologics Development team that helps bring solutions to transform the lives of people with severe diseases. This role will be based at our clients state of the art facility in Slough on an initial 6 month contract.

The Company:
Our client is a global biopharmaceutical company whose medicine treats thousands of patients around the world who live with severe diseases.

This role is located on a well-established biopharma R&D facility based in Slough. There are good transport links whether you drive or even use public transport. Slough is a great place to live and work and is easily commutable from Reading, Oxford and London.

The Role:
As the QA Specialist you will be responsible for providing advice and support on operational Quality Assurance activities to the teams working drug substance and drug product development, technology transfer, manufacturing and submission preparation.

Additional responsibilities will include:
- Review and approval of documentation including tech transfer protocols, manufacture and analytical testing, quality agreements, analytical validation to ICH Q2 and review batch documentation.
- Ensuring compliance with relevant guidelines.
- Ensuring deviations and change controls are properly dealt with.

In order to be considered for this QA Specialist vacancy you will have the following qualifications, skills and experience:
- Qualification in a scientific subject.
- Experience working in the biologics industry.
- GMP QA and submission of marketing authorisation knowledge and experience.
- Previous experience of working in the pharmaceutical biologics industry.
- Proven experience in project management in QA.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46121 in all correspondence.

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