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Quality assurance officer

Leicester
Walker Cole International Ltd
Quality assurance officer
Posted: 10 January
Offer description

Walker Cole International is supporting a regulated life sciences manufacturer in the appointment of a Quality Assurance Officer on a Fixed Term Contract within their Sterile Manufacturing Quality function. This role offers the opportunity to act as a key QA liaison in an aseptic manufacturing environment, supporting both marketed and investigational medicinal products. As a Quality Assurance Officer, you will be responsible for: * Acting as the primary QA point of contact for Sterile Manufacturing operations. * Managing GMP deviations, quality incidents, OOS results, complaints, and CAPA activities. * Performing batch record review, change control, SOP review, and New Product Introduction support. * Planning and conducting internal audits, Gemba walks, training, and supporting client and regulatory audits. To be successful in this role, you will have: * A relevant life science-based degree or above * Experience in aseptic sterile pharmaceutical environments * Strong working knowledge of GMP, ISO 13485, EU GMP (EudraLex Volume 4), and FDA 21 CFR. * A proactive, detail-focused approach with strong communication and stakeholder engagement skills. Keywords: Quality Assurance | QA Officer | Sterile Manufacturing | Aseptic | GMP | Good Manufacturing Practice |ISO 13485 | CAPA | Deviations | OOS | Internal Audits | Batch Review | Regulatory Compliance...

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