Quality Officer - 6 Month FTC

Location

Hengoed, Caerphilly | United Kingdom

Job description

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 Quality Officer to join Norgine on a 6-month FTC. The person holding this position will report to the Senior Quality Assurance Officer and be a member of the Quality department.

The core responsibility of the of the Quality Officer is to support the QP in the execution of their legal and routine duties. To perform batch review, either as a delegated duty from the QP or as a QP, in support of the certification process, and to coordinate and perform investigations related to product quality complaints and liaise with market QMRs.

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

KEY RESPONSIBILITIES & 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.
• 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

Requirements

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

Benefits vary between locations.

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

Anti-discrimination and equal opportunities:

· Norgine prides itself on its integrity, honesty and fairness in all aspects of our business. We aim to create a safe, welcoming and engaging workplace.

· Norgine provides equal opportunities to all employees and is strongly committed to the principle of equality regardless of race, religion or belief, age, nationality, sex, disability, pregnancy/maternity, gender reassignment, marital or civil partnership status, or sexual orientation.

· Norgine does not condone any discriminatory acts or attitudes in the conduct of our business between our employees or with external parties. This includes unlawful harassment and victimization.

Job tags

Salary