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 on a fixed term basis for up to 12 months to cover maternity leave. 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, revision of and issue of operational GMP documentation within Quality Assurance including SOP and material specifications.
- Administration, coordination and review of applicable GMP documentation.
- Supporting Cobra’s vendor assurance process, including supplier and contractor assurance, complaints and change notifications.
- Facilitating the timely follow-up and closure of deviations, change controls and CAPA.
- Working collaboratively with Operations/ QC to actively maintain GMP standards.
- Supporting, when necessary, QA Team Leaders to deliver on time products and processes in compliance with current GMP and regulatory guidelines.
You will ideally possess a Science degree (or equivalent), with proven relevant experience in a manufacturing or quality assurance role and have good working knowledge of GMP. Ideally you will have gained your experience in the bio-pharmaceutical sector but this is not essential.
You will have excellent communication skills (verbal and written) and the ability to interact at all levels of the organisation. In addition, you will be a proactive team player, both within the department and across the organisation, and be willing to adopt and implement change.