quality assurance specialist

Essential for the role:

• MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment (manufacturing, packaging or analysis).
• Demonstrates understanding of international quality systems regulations, concepts, and industry practices to adopt best-in-class processes.
• A comprehensive understanding of GMP regulations, the pharmaceutical development process and the supply chain process would be advantageous.
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude.
• Excellent teamwork and networking skills and encourages team effectiveness.
• A good communicator with experience of interacting effectively across interfaces, collaborating internally.
• Fluent in written and spoken English.

Working in the Site Quality team means you will work closely with the internal assets/facilities, teaming up with the pharmaceutical development functions and be involved in cross business processes. To build strong relationships with these functions knowing their business is key, to give support to projects and develop ways of working that builds for success.

The ability to interpret and trend compliance data to measure and improve quality standards is key. You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting.

Whilst taking on your own specialist areas and making good quality decisions, you will be encouraged to think strategically and use your problem solving skills to resolve any quality issues. You will participate and contribute to continuous improvement projects with the aim to standardize and simplify our internal processes.

Typical Accountabilities:

• Responsible for quality release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
• Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects related to drug product
• Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
• Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working