- 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 (Quality Systems) 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.
Main duties include:
Creation, revision, review and issuance of GMP documentation within Quality Assurance
Administration, coordination and review of GMP manufacturing documentation.
Supporting the Sites Vendor Assurance System, including coordination and review of documentation associated with Supplier and Contractor Assurance.
Supporting the routine use and maintenance of the electronic QMS system
Facilitating the timely follow-up and closure of deviations, change controls and CAPA.
Working collaboratively with the Operations team to actively maintain GMP standards.
You will ideally 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, 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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