Global Development Quality Specialist - Student Placement
This role will be based in our brand new, state-of-the-art co-working facilities in Moorgate, London. This site, at the heart of London provides fantastic amenities, support services and collaborative workspaces with convenient transport links.
Who we are…?
For more than a century, our organisation has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our organisation continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification for the fourth year running.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Development team ensure production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.
We currently have a unique and exciting opportunity for a one-year industrial placement within our Development Quality department. This department performs a key role in enabling and approving manufacture and release of new products for use in Clinical Studies across the world.
- Completes quality review of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to Standard Operating Procedures (SOP’s), Good Manufacturing Practice (GMP’s) and applicable regulations
- Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOP’s, GMP’s and regulatory requirements, including supporting Qualified Person (QP) certification
- Work cross-functionally, developing strong working relationships and knowledge of other roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review
- Assist with product recalls and stock recoveries as appropriate
- Identify compliance gaps and make recommendations for continuous improvement
- Creates and maintains assigned SOP’s
- Perform and review complaints and deviation investigations, change controls and Corrective Action and Preventative Action (CAPA’s)
- May assist in the induction process for new starters
- Follows standard procedures and consults with manager/supervisor on exceptions
- Compiles data for reports and presentations - May interpret data and draw conclusions
- Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements
- Keep abreast of current GMP requirements as described in applicable worldwide regulations
- Additional activities may be assigned by the manager/supervisor
- You will be looking to complete a 12-month placement in your third or penultimate year of study, returning to your course at the end of the placement
- Studying towards a degree in Chemistry, Biochemistry, Pharmaceutical Sciences or a related discipline (or equivalent qualification)
- Demonstrates problem-solving skills and ability to use your initiative
- Demonstrates attention to detail
- Effective time management and the ability to work under pressure
Qualities we look for
- Operates with a high level of integrity, transparency and accountability
- Comprehends and aligns with our organisation’s core values
- Aligns and fosters a culture of diversity and inclusivity
- Demonstrates initiative, proactivity and academic curiosity
- Encourages and boosts their colleagues through teamwork
- Demonstrates clear and effective communication
- Demonstrates a desire to learn and improve their performance through feedback
- The willingness and the ability to work cross-functionally with a team-orientated approach