Quality Assurance Officer

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Norgine

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

The person holding this position will report to our senior quality officer and be a member of the Hengoed quality team.

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

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.

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.

Maintains excellent working relationships with all departments across Hengoed site;
Liaise with other manufacturing sites within Norgine and through the External Network Structure.

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.

Don't forget to mention EuroPharmaJobs when applying.

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