As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

 

We are currently looking to recruit a Quality Assurance Officer to work in the Quality department at our Keele facility.

 

The main duties will include:

 

  • Creation and revision of GMP documentation within Quality Assurance.
  • Administration, issue, coordination and review of GMP manufacturing documentation.
  • Providing ‘in suite’ operational QA oversight of GMP manufacture in Grade D and Grade C Facility.
  • Providing Facility Systems support, including HVAC, Pressures, Temperature, Cleaning Logs, Room Release and Room Inspection.
  • Providing support for the timely follow-up and closure of Deviations, Change Controls and CAPA.
  • Assisting as required with internal, supplier and external audits.
  • Working collaboratively with Operations to actively maintain GMP standards.

 

You will be educated to degree level or equivalent in a Science subject, with proven relevant Pharma experience in a Manufacturing or Quality Assurance role. You will have good working knowledge of GMP, ideally in the bio-pharmaceutical sector but this is not essential.

 

You will demonstrate effective communication skills (verbal and written) and the ability to interact at all levels of the organisation. You will be a proactive team player, both within the department and across the organisation, who is willing to adopt and implement change.

 

This role will be based at Keele, Staffordshire.

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