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 (Eudra Lex Volume
4), and FDA 21 CFR.
* A proactive, detail-focused approach with strong communication and stakeholder engagement skills.  | QA Officer | Sterile Manufacturing | Aseptic | GMP | Good Manufacturing Practice |ISO 13485 | CAPA | Deviations | OOS | Internal Audits | Batch Review | Regulatory Compliance