Senior Quality Assurance Officer

ABOUT THE JOB

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 Senior Quality Assurance Officer to join Norgine.

The person holding this position will report to Senior Quality Assurance Manager and be a member of the Quality Assurance team.

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

Requirements

MAIN PURPOSE:

• Maintain, 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 support the batch documentation review process
• 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 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

·       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

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

Benefits

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

Sound good? Find out more about the career you’ll have with Norgine, then apply here.