Quality Assurance Officer

1 week ago

Bristol, United Kingdom LiCa Scientific Ltd Full time

Quality Assurance Officer

Permanent role

Bristol

Competitive salary + package (competitive pension, private medical, generous holidays, income protection scheme/critical illness cover)

Our client is a cutting edge research company working across the life sciences and clinical diagnostics areas.

They are seeking a Quality Assurance Officer (QA) who will work on product quality, customer satisfaction, continuous improvement, environmental impact minimisation and other QA fields.

What you’ll do:

Our client is a world-leading developer of life science reagents, and you will be joining a QA team which is currently in place and expanding into new facilities. The role will work in a defined segment of the business on activities detailed below, covering Quality Assurance tasks relating to development and manufacture of life sciences products.

This is an exciting opportunity for a QA Officer to help maintain the current Quality Systems as well as get involved in continual improvement of these systems. We are interested both in those experienced in QA and those looking to move over from a related field into QA, such as Analytical Chemists.

Key Responsibilities will include:

  • Batch Record review and product: Review, approval and release of Batch Production Records and Quality Control testing data.
  • Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
  • CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
  • Documentation Management: Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
  • Change Control: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
  • Training: Organise and participate in internal quality related training sessions.
  • Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings, and tracking completion of corrective actions.
  • Supplier Quality: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials. Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
  • Any other task as required by the business.

Your Background:

  • Degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
  • Experience/Understanding of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
  • Experience/Understanding of working within a cGMP environment is a top-line requirement for this role (please do detail your experience in your application or covering information).
  • We are interested in candidates working in other areas of life sciences quality, such as Analytical Chemists, who seek a move into Quality Assurance
  • Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.

On this occasion, LiCa Scientific is acting as an employment agency.

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