QA Team Leader Operations
We are currently looking for a QA Team Leader Operations to join a leading Clinical-stage Gene Therapy company based in the London area.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Team Leader Operations will be varied however the key duties and responsibilities are as follows:
1. Lead, Supervise, manage and train the QA Quality Operations team and continuously improve the local Quality system.
2. Assure compliance to EU and FDA GxP, Company QMS and QA GMP operations, any other applicable regulations/standards.
3. Oversight, review and management of Risks, Quality Events including incidents, deviation, investigations, change controls and CAPA ensuring they meet timelines.
4. Ensure that own work and teams work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g., SOP's, BMR's, Protocols, Guidance's, etc.
To be successful in your application to this exciting opportunity as the QA Team Leader Operations we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science based degree e.g. Chemistry, Biology, Pharmacy.
2. Experience in leadership within QA and experience of working within a Sterile/ Aseptic GMP manufacturing environment.
3. A working knowledge and practical experience with defining and implementing Quality Management Systems.
Key Words: GMP, GxP, QMS, QA, Quality Assurance, Sterile, Aseptic, FDA, Biologics, Clinical, Quality, GDP