Our client, a global biotech company based in Speke, are looking for a QA Associate to join their QA department. The role holder will be responsible for working cross-functionally and reviewing and compiling batch specific documentation and data for batch release, ensuring compliance with licensed and cGMP requirements, escalation of potential issues, and timely submission of LRPs/release of batches in order to meet supply demands.

The role holder is also responsible for completion and on time closure of PTC/deviation investigations, ensuring potential trends are identified and escalated, robust investigations performed, appropriate CAPAs implemented. A key aspect is to provide quality support and oversight to other functions and projects as defined by the quality assurance manager, working cross-functionally, and instilling and promoting a quality culture.

This is a temporary role for 6 months to start 24th May - Monday - Thursday 8am - 4.45pm & Fri 8am - 1pm.

Key Responsibilities:

  • To work with other QA colleagues to ensure that batch specific documentation and data, including batch release packs and lot release protocols, are reviewed and compiled for QA Manager/QP release. Ensuring compliance with licensed and cGMP requirements, identification and resolution/escalation of issues that may impact submission/release, and timely release of batches in order to meet strict supply demands. To ensure that other team objectives are achieved and to monitor this progress, suggest and support execution of required work, and suggest and implement improvements.
  • To perform PTC /AE activities, as required, to ensure root cause investigations are completed in a timely manner and critical items are escalated to management.
  • To have an active involvement in site quality systems, deviations, change controls, SOPs and self-inspections. Actively maintain and promote a cGMP compliant culture, ensuring the highest standards of Housekeeping and Safety are applied in the team, in accordance with current regulations and procedures. To be permanently inspection ready, ensuring that the review, storage and archive of cGMP documentation and batch specific records is up to date and at the required standards.
  • To participate in improvement project teams, where required, driving quality decisions and providing advice and technical support, where required. Coordinate completion of any resulting activities. Demonstrate creative problem solving within cGMP constraints and align with best practice.
  • To perform training required for own role and keep own training records up to date.
  • To cross-train in activities which will allow contribution and support to activities in other QO departments, as required by the business

Key Skills/Experience:

  • Knowledge of cGMP regulations and background in the Pharmaceutical industry
  • General experience of Quality Management Systems
  • Graduate level in relevant discipline or suitable alternative or equivalent experience within industry
  • Experience of working in a cGMP environment
  • Experience of Quality Assurance systems, procedures and industry practices desirable
  • Proven time management skills for planning and schedule of work
  • Proven Communication skills both written and verbal
  • Ability to work as a member of a team, but flexible to work on their own
  • Computer Literate
  • Fluency in English

Required skills

  • Pharmaceutical
  • QA
  • Quality Management
  • Batch Release
  • cGMP

Application questions

Do you have knowledge of cGMP regulations and background in the Pharmaceutical industry?
Do you have experience of Quality Management Systems?
Do you have experience of Quality Assurance systems, procedures and industry practices?

Reference: 42681227

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