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.