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 (QA) Officer at our Keele facility. Reporting to a Quality Leader, the QA Officer will assist in the maintenance of the Cobra Biologics Quality System to help ensure that processes and products comply with appropriate Regulatory requirements.
The main duties will include:-
- Creation and revision of operational GMP documentation within Quality Assurance including SOP System Coordinator
- Administration, coordination and review of GMP manufacturing documentation.
- Providing ‘in suite’ operational QA oversight of GMP manufacture.
- Providing Facility Systems support, including HVAC, Pressures, Temperature, Cleaning Logs, Room Release and Room Inspection.
- Facilitating the timely follow-up and closure of Deviations, Change Controls and CAPA.
- Working collaboratively with Operations to actively maintain GMP standards.
The ideal applicant should ideally possess a Science degree (or equivalent), have at least 2-years relevant Pharma experience in a Manufacturing or Quality Assurance role, and a good working knowledge of GMP; ideally in the bio-pharmaceutical sector but this is not essential.
The successful candidate should demonstrate effective communication skills (verbal and written) and the ability to interact at all levels of the organisation.
He/She will need to be a proactive team player, within the department and across the organisation, who is willing to adopt and implement change.
Applications should be sent in writing stating the appropriate reference number with full C.V. and current salary details to: Marie Cusworth, Human Resources Administrator.