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.

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

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. xiskglj

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