Quality Assurance Officer

4 months ago

Hengoed, United Kingdom Norgine Full time

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Quality Assurance office to join Norgine in.

The person holding this position will report to the Senior Qiuality Assurance Officer.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

**MAIN PURPOSE**:
To carry out key responsibilities within Quality Assurance as listed below.

**Requirements**:

- Review batch documentation and any associated deviations to ensure satisfactorily completed prior to batch certification by the QP or responsible person for Medical Devices.
- Maintain, support and improve the QMS employed within Norgine and to promote continuous improvements, whilst maintaining compliance with regulations and standards for medicinal product and medical devices.
- To manage and perform internal self-inspections and external audits, including vendors and suppliers, for commercial and investigational medicinal products
- To support the QP in the execution of their legal and routine duties.
- Maintain key quality documents, including, but not limited to, the site master file, inspection evidence files & Quality related SOPs.
- Coordinate and perform investigations related to product quality complaints and liaise with market QMRs.
- Supply information for, coordinate execution & review of Product Quality Review process.
- To support the ONE Norgine model particularly with regards the Global Quality.
- Supporting delivery of site quality objectives and support of Global Quality objectives.
- Creation of Quality Agreements for commercial partners

**MAIN TASKS**
- To perform batch review, either as a delegated duty from the 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.

**RELATIONSHIPS**:
Maintains excellent working relationships with all departments across Hengoed site.

Liaise with other manufacturing sites within Norgine and through the External Network Structure.

**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

**Benefits**

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

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