Voir tous les résultats
Head of Quality Control
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: The Head of Quality Control will be responsible for providing effective leadership, assistance and guidance to ensure that Quality objectives meet the necessary standards in line with Good Manufacturing Practice (GMP) and other applicable regulatory requirements. You will report to the UK Director of Quality.
Your key responsibility is to provide QC support across Operations areas Locally and Globally, and to constantly work within Operational departments to reduce the risk of quality findings.
Essential job functions include, but are not exclusive to:
- Named on MHRA GMP Manufacturing licenses as Head of Quality Control
- Legal responsibility for QC for manufacturing and manufacturing directed release testing
- Assess and advise on release specifications and / or reject raw materials Evaluation of batch records to perform QP release of interim Drug Substance
- Approve and monitor internal and contract analysis testing
- Approve characterization and release testing on manufacturing specifications
- Ensure that out of specifications (OOS) and deviations are appropriately investigated and resolved
- Ensure all manufacturing directed testing and Product testing is performed accurately and appropriately.
- Review and approve assay validation protocols and reports
- Participate in continuous improvement projects (Local and Global)
- Prepare appropriate Standard Operating Procedures (SOP) and training modules when required and carry out the training.
- Be a member of on-site management team and attendance at leadership meetings (Local and Global)
Who you are:
- Degree, or equivalent, in relevant life science. Advance degree preferred
- Eligible to be a permanent Qualified Person for commercial and Investigational products
- Extensive hands-on experience in Quality Control
- Proven experience at a senior level leading a QC function in a life science GMP/FDA regulated environment, such as pharmaceutical and biopharmaceutical devices and diagnostics.
- Experience with common continuous improvement tools (e.g.six sigma).
- Extensive knowledge of EU/US GMP/GLP and related standards
- Technical experience of a wide range of biological testing techniques
- Proven ability to lead change through an organization
- Commercially aware
- Knowledge of Quality Risk Management.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!