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QA Manager - GMP

Employer
CK Group
Location
Oxford
Salary
£50000 - £60000 per annum
Closing date
28 Dec 2021

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Sector
Quality Assurance
Contract Type
Permanent
Hours
Full Time
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Job Details

CK Group are recruiting for a highly experienced QA Manager to join an innovative biotech company. This will be an office based role in Oxford on a permanent basis with flexibility of home working. This role would be ideal for a candidate with strong expertise in QMS within a GMP regulated environment.

The Company:
Excellent opportunity to join a small biotech with a focus in oncology.

The Role:
- Provide operational support including maintenance of the GMP quality systems, both internal and through third parties, and to be a key member of the Quality Management Team.

Responsibilities
- provide support to the Quality Team Leadership across a broad range of responsibilities, including:
- Quality Management Systems (QMS) - contribute to the development and maintenance of QMS
- Quality Assurance and Quality Control - develop and review quality project plans ensuring they run to schedule
- Third Party Quality Assurance - support appropriate vendor selection and supplier qualification

Your Background:
- Minimum BSc in a Chemistry, Biology, Pharmacy or related life science.
- Experience in a GMP environment and managing GMP compliance activities.
- GMP auditing experience.
- Demonstrable experience in contributing to all clinical quality matters leading to regulatory submission, clinical protocols, conduct of clinical trials, according to all regulatory and GMP standards.
- Experience of International GMP/ICH and clinical quality laws, regulations and guidelines.
- Extensive experience in QMS and risk-based auditing within a pharmaceutical manufacturing organisation including experience in conducting an on-site audit of a vendor and clinical trial site.
- Proven experience in GMP auditing associated with chemical API and excipient manufacturers and suppliers; packaging suppliers; and solid oral dosage form manufacturers
- Experience providing internal consultation and training on quality systems and GCP.

Apply:
For more information or to apply for this position, please contact Naynesh Mistry on 01246 457703 or via email on nmistry@ckgroup.co.uk, quoting job ref 52331.

It is essential that applicants hold entitlement to work in the UK.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Find Us
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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