Quality Officer
Norgine, United Kingdom

MAIN PURPOSE:

To carry out key responsibilities within Quality Assurance as listed below.

KEY RESPONSIBILITIES amp; ACCOUNTABILITIES:

• Review batch documentation and any associated deviations to ensure satisfactorily completed prior to batch certification by the QP or responsible person for Medical Devices/Products.
• 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 amp; Quality related SOPs.
• Coordinate and perform investigations related to product quality complaints and liaise with market QMRs.
• Supply information for, coordinate execution amp; 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 amp; 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.

Job Rewards and Benefits