Quality Assurance Officer
Posted 1 day ago by Walker Cole International
£40,000 Per year
Undetermined
Undetermined
East Goscote, England, United Kingdom
Summary: The Quality Assurance Officer role at Walker Cole International involves overseeing quality assurance within a regulated life sciences manufacturer, specifically in sterile manufacturing. This fixed-term contract position requires acting as a key QA liaison in an aseptic environment, managing various quality-related activities, and ensuring compliance with regulatory standards. The successful candidate will need a relevant life science degree and experience in aseptic pharmaceutical settings.
Key Responsibilities:
- 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.
Key Skills:
- 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.
Salary (Rate): £40,000.00 yearly
City: East Goscote
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.
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