As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. 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 to join the Quality department at our Keele facility. Reporting to a Quality Leader, the QA Officer will assist in the maintenance and continuous improvement of the Cobra Biologics Quality System, ensuring that processes and products comply with appropriate Regulatory requirements.
The main duties will include:-
- Providing support to the site QMS System, including review of master and executed operational GMP documentation; this being the primary focus of the role.
- Working collaboratively with Operations in order to actively maintain GMP standards.
- Coordinating and performing (under supervision) internal and supplier audits.
- Facilitating timely follow-up and closure of Deviations, Change Controls and CAPA.
- Providing Facility Systems support, including HVAC, Pressures, Temperature, Cleaning Logs, Room Release and Room Inspection.
- Providing Quality support for validation activities.
- Providing Quality support for Product shipments.
The ideal applicant must ideally possess a Science degree (or equivalent), or have at least 3-years relevant Pharma experience in a Manufacturing or Quality Assurance role, and have a good working knowledge of GMP; ideally from the Bio-pharmaceutical sector, but this is not essential.
The successful candidate should demonstrate effective communication skills (verbal and written).
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.