Quality System Project Lead Kent
Contract / Kent, UK
Quality System Project Lead cGMP- Kent
We are currently working with leading niche Pharmaceutical company who specialise is researching and developing prescription medicines to meet patient needs in a wide range of therapeutic indications. Along with the commercial roll out of their key product for patients with Multiple Sclerosis, the company has a number of trials are planned for countries across the world
- This role is for a fixed term contract to manage the project to overhaul and upgrade the quality system used within the business by strengthening and rationalising it to a single company compliance system
- You will be responsible for the delivery of the Quality System development project within the constraints of the agreed schedule and budget
- You will report to the Director of Quality and working closely with the PAI Program Lead,
- You will utilise your extensive GxP knowledge and excellent compliance and communication skills to oversee the quality system upgrade project the manufacturing and development function, including the clinical studies programme.
- You will also provide support, advice, education and training to other departments including crossover between cross-functional areas such as, GCP, GMP, GLP, & Computer Systems Validation as you increase the level of integration across sites.
- You should have proven experience in an MHRA/FDA regulated environment including managing a team.
- You must have an excellent working knowledge of current ICH, EU and US regulatory requirements. Experience with non-sterile dosage forms such as oral liquids and capsules, and natural products would be advantageous including botanicals
- Reporting to the Director of Quality and based at the company's main manufacturing site, you will need to show leadership and an ability to influence key stake holders to achieve your objectives
- A bioscience degree or chemistry/pharmacy qualification
- Broad experience of GxPs, especially cGMP, GCP and CSV
- Must have worked in a GxP or regulatory environment at management level
- A working knowledge of US FDA cGxP requirements would be advantageous
- A full clean driving licence is required
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