Senior Quality Assurance Officer

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Senior Quality Assurance Officer

Norgine

Hengoed, United Kingdom

MAIN PURPOSE:

Support and improve the QMS employed with Norgine, Hengoed 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
To provide support to site projects
Maintain key Quality documents, including the Site Master File
Ensure the provision of validation advice and support to site initiatives as required
To support the ONE Norgine model particularly with regards to Quality
Supporting delivery of site Quality objectives and support of wider business objectives
Creation of Quality agreements
Responsible for the Quality oversight of Pharmaceutical Development
Responsible for the direct line management of Quality teams (defined by team allocation), including Quality Officers and Quality Technical Administrators, and the performance management and individuals’ developments.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Perform delegated duties of the QP
Direct Quality Assurance Officers and Quality Technical Administrators
Generation of key performance indicators
Maintenance and improvement of QMS

MAIN TASKS:

To perform batch review as a delegated duty from the QP
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 indicators for M & S and Pharmaceutical Development
To review and approve Quality related documents for the site
To support and facilitate internal and external inspections
Undertake responsibility for the direct management of Quality Officers and Quality Technical Administrators
Reporting Quality related KPIs 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, validation summaries
To manage and develop a team of Quality professionals through performance management, with the aim of delivering the Quality professionals through performance management, with the aim of delivering the Quality and site objectives
To maintain expertise and current knowledge of all areas of Quality, relevant legislation and production processes to fully support maintenance and improvements of equipment and processes, providing advice as required
Maintain the manufacturing site licenses
Comply with all statutory and company requirements for health and safety
The above list is not exhaustive and the job holder may be expected to perform other reasonable tasks within the boundaries of their skills, in the interest of the job and the company’s performance

RELATIONSHIPS:

Maintains excellent working relationships with all departments across Hengoed site
Liaise with other manufacturing sites within Norgine and through External Network structure
Pharmaceutical Development and Project Teams

SKILLS & KNOWLEDGE:

A degree or equivalent in a science or engineering subject is preferred
A minimum of 5 years relevant experience in a Quality environment in the pharmaceutical industry
Line management experience
Strong communication and supervisory skills are essential
The ability to introduce, co-ordinate, complete and report on projects
A high level or self-motivation is necessary
Attention to detail
Able to rationally persuade
Influencing skills
Ability to perform audits, internally and externally

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