QA Associate – £17.79-23.66 ph

Currently recruiting for a QA Associate for our client in the pharmaceutical industry.

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. Thereafter, the role holder will be a member of the Frontline QA team, primarily aligned to Secondary operations.

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

Initial Hours: Mon – Thu 8am – 4.45pm & Fri 8am – 1pm, (rate £17.79)

Then will move to 4 on 4 off shifts: in campaign (rate £23.66) and out of campaign (rate £21.70)

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.

Experience:

  • Good knowledge of cGMP requirements and applicable process 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

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