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Quality Assurance

3 months ago

Hengoed, United Kingdom Norgine Full time

**Norgine are looking to recruit a Quality Assurance (QA) Officer on a fixed-term basis till the end of June 2024.**
You will have experience in building excellent working relationships, and liaising with multiple manufacturing sites.

**Main Tasks**:

- To perform batch review, either as a delegated duty from the Qualified Person (QP) or as a QP, in support of the certification process.
- To assist and facilitate the identification, assessment, investigation and reporting of quality incidents.
- To provide advice and training on all quality related matters including but not limited to GMP, ISO standards, validation, and auditing.
- To maintain an overview of quality compliance through the effective use of key performance indicators.
- To review and approve quality related documents for the site
- To support and facilitate internal and external inspections.
- Reporting Quality related KPI’s to the site and globally.
- Lead, participate and support projects to enable continuous improvements
- Preparation of quality related documentation, including but not limited to the SMF, GMP training, monthly and quarterly reports.
- Maintain the manufacturing site licences.

**SKILLS & KNOWLEDGE**:

- A degree or equivalent in a scientific discipline is preferred with experience in a Quality. environment in the pharmaceutical industry.
- Strong communication skills are essential.
- The ability to introduce, co-ordinate, complete and report on projects.
- A high level of self-motivation is necessary.
- Attention to detail.
- Able to rationally persuade.
- Influencing skills.
- Ability to perform audits, internally and externally.

To be considered for this role, you must apply

Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing