QA Associate – £20.89ph

Our client, a global pharmaceutical company based in Speke is Currently recruiting for a QA Associate.

The role holder will be a Quality member of the Secondary Frontline QA team. The role holder will initially be responsible for supporting the commercial readiness of the new Filling, Inspection and Packaging operations.

This is a temporary role for 12 months possibly longer and an immediate start.

The shift pattern is 4 on (2 days and 2 night) 7-7 (12 hr shifts) and then 4 off.

The role is paying £20.89 per hour and is a high calibre position.

Key Responsibilities:

• Providing cGMP and Quality support and guidance to the Secondary projects/operations and its support functions.
• Perform QA Frontline duties during campaign operation of the Fill/Finish production lines (Filling, Inspection, Packaging), including technical and qualification batches as required.
• Provide QA support to the wider business, as and when required by the Quality Assurance Manager.
• QA review and approval of procedures, batch production records (master and executed), and any other relevant cGMP documentation.
• Work as a member of cross-functional teams as defined by the Quality Assurance Manager. The role holder must be confident in making Frontline Quality decisions.
• Deviation/CAPA and Quality System support
• Promote a Safety, Quality and cGMP culture in the team and across the site
• Perform training required for own role and keep own training records up to date

Key Skills/Experience:

Education:  

• Graduate in a relevant discipline, or able to demonstrate capabilities to this level.
• Have a good knowledge of cGMP requirements and applicable process knowledge.

Experience:

• Previous cGMP knowledge.
• Experience in QA (ideally).
• Experience working in a pharmaceutical environment.
• Experience working in Secondary (Fill/Finish) and/or aseptic operations (ideally).
• Understanding of EU and FDA regulatory requirements.
• General experience of Quality Management Systems.

Other:

• Competent IT skills, particularly MS Excel and Word.