QA Team Leader – Operations

Location
London
Salary
£45000 - £55000 per annum
Posted
14 Jun 2021
Closes
14 Jul 2021
Ref
J5635051
Contact
Isobella Mcneish
Contract Type
Permanent
Hours
Full Time

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.

ROLE REQUIREMENTS:

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

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