Quality Assurance Officer

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.