Quality Assurance Lead

CK Science are recruiting for a Quality Assurance Lead to join a leading biotechnology company based in Dundee on a 12 month fixed term contract basis.

The Quality Assurance Lead Role:
Your main duties will be to:

- Oversee the independent approval of raw materials, process intermediates and finished product by Quality Record Audit of Device History Records and physical inspection of materials to cGMP and company procedures.
- Perform batch review/release activities and regular cGMP/Quality System Audits and record findings with CAPA system.
- Raise, review or approve nonconformance records, CAPA records, Change Control record and Design Verification & Process Validation.

Your Background:

- Considerable experience in a Quality Assurance position, ideally working to ISO13485 or in highly regulated sectors i.e. pharmaceuticals.
- Experience of working practice within regulated or quality areas e.g. ISO13485, 21CFR820 with awareness of the following areas; production and process controls, cGMP, auditing, CAPA Processes, Change Management, Supplier Management.
- Self motivated with excellent communication and time management skills.

Apply:
For more information or to apply for this Quality Assurance Lead position, please contact Mary Bolt on 01246 457729 or email mbolt@ckscience.co.uk, quoting job ref 48840.

It is essential that applicants hold entitlement to work in the UK.