An international leader in the manufacture and supply of aseptically manufactured pharmaceuticals to the healthcare sector is currently looking for a CMO Quality Assurance Manager for their site near Uxbridge.
This role will be the Quality Assurance lead for all Contract Manufacturing Organisations and be responsible for managing the QMS for each customer requirement whilst also managing multiple tech transfer projects across the EU. The role will grow quickly in scope with a future plan to have matrix reporting across a global CMO team.
The CMO Quality Assurance Manager will also support the standardisation of the Quality Management System with regard to an existing and newly acquired product portfolio that is manufactured at a range of CMO locations across the globe.
CMO Quality Assurance Manager key responsibilities:
- Supporting the management of quality operations to ensure compliance with GMP and Marketing Authorisations.
- Ensure documentation and processes across CMO's including, vendor and supply chain management, batch release, recall management, product quality reviews
- Support technical transfer and new product introduction projects to transition acquired products into the portfolio.
- QA related tasks with third party CMO's ensuring performance in compliance with GMP and company standards.
- QA oversight and GMP compliance for new and current products including process validation, master documentation approval and implementation of quality agreements.
- Active member of the management review and quality strategy teams
- Strong technical knowledge of EU GMP regulations and guidelines and experienced in the operation of an EU regulatory approved QMS
- Experience within a sterile pharmaceuticals manufacturing environment
- Involvement in and a good understanding of the tech transfer process
- GMP auditing knowledge and practical skills, hosting and performing
A salary of £60,000-£65,000 is on offer and Interviews will be taking place week commencing 27th May and 3rd June so please apply as soon as possible to be considered for shortlisting.
You can apply via the link provided or contact James Ivall at Goodman Masson on 02073 240538 if you require more information.
Look forward to hearing from you.