QA Associate

Our client a Global Biotech company, based in Speke is looking for a QA Associate to join their Quality team.

This role is to start in January and to last for 6 months with scope to extend and go permanent for the right candidate.

Key Responsibilities:

  • The role holder will be a Quality member of the Fill/Finish (Secondary projects) project team, providing QA support for the delivery of an effective and compliant Fill/Finish operational facility.
  • The role holder will be responsible for providing cGMP and quality support and guidance to the Secondary projects/operations and its support functions.
  • The role will be required to perform QA Frontline duties during technical and qualification batches, including media simulations, and commercial batches once the Fill/Finish facility is commercially operational.
  • The role holder will be responsible for QA review and approval of procedures, master batch records, and any other relevant cGMP documentation. They will also work as a member of cross-functional teams as defined by the Quality Assurance Manager.
  • The role holder will also be required to provide QA support to the wider business, as and when required by the Quality Assurance Manager.
  • The role holder must also confident in making frontline Quality decisions.
  • Role requires making quality-based decisions; for example, those associated with batch records, deviations, validation activities. Work schedule prioritisation decisions are also required, and some decisions associated with training. Decision when to escalate issues associated with both these areas accordingly.

Key Skills/Experience:

  • Manufacturing QA experience is essential.
  • Manufacturing in secondary would be a great advantage.
  • Secondary Aseptic experience very desirable.
  • Candidate needs to be flexible due to unionised work patterns which will interchange. This will be discussed on the call.
  • Reason for shift patterns is due to the project phases and what is required throughout the process. Once the project meets qualification stage there will be a need for 24 hours QA Manufacturing support hence the days and night shift pattern.
  • After Validation/filling phase the role will revert to either standard days or 4 days on, 4 days off pattern (11-hour shifts).
  • It is highly likely that the role will be extended and there is scope for it to go permanent for the right person.
  • Role holder will be expected to carry out validation process, SOPs, batch record drafting, approvals.
  • Training will be provided on how the line works and the process and procedures the company follows.
  • The role holder will then be expected to hit the ground running performing, manufacturing issues, online checks, escalating problems and so on.
  • Looking for someone with QA Manufacturing experience (ideally 3-4 years but depends on individual).
  • Pharma experience is necessary as is GMP.
  • Candidate would have ideally worked within an aseptic environment (Grade A-C clean room)
  • This is a project to build this division. The project will be in three stages and this part is stage 2.
  • Important you have the right mindset. Motivation, good communication skills, inter personal skills and building relationships with other departments is crucial.
  • Currently 4 people in the team but line manager is looking to have a team of 10 people within the next 2 years so option for permanent position will be decided closer to July 2020.
  • The candidate will be coming in at the early stages of the project which is a bonus as if the position goes permanent, they will be in a good position for their career.
  • There will be a 1 stage interview which is face to face with the line manager at the beginning of January. The role is to be filled at the end of January/beginning of February 2020.

Required skills

  • EU
  • Laboratory
  • Pharmaceutical
  • QA
  • Quality Assurance

Application questions

Do you have QA experience?
Have you worked within a pharmaceutical environment before?
Do you have cGMP knowledge?

Reference: 39558031

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