Category

Description

• • Training system: Maintenance of the site Training System; Organise and participate in internal quality related training sessions.
  • Documentation Management: Writing, reviewing and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
  • Change Control: Participation in the change control process to ensure all changes to procedures and processes are assessed and implemented correctly.
  • Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations, out of specifications and observations.
  • 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.
  • Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings and tracking completion of corrective actions.
  • Batch Record review and product release: Review, approval and release of Batch Production Records and Quality Control testing data.
  • Supplier Quality: Assist in the implementation of a process of QA approval of incoming materials and approval of QC testing for incoming materials.
  • Regulatory issues: To ensure compliance with relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products and raw materials.
  • Technical Support: Providing technical support as required to customers and resolving any associated customer complaints.
  • Working as part of the ISO 9001:2015 implementation team.
  • Any other task as required by the business

• • BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
  • 2 years’ experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
  • 2 years’ experience of working within a cGMP environment.
  • Experience of working to ISO 9001, ISO 13485 or 21CFR part 820.Desirable:
  • Experience of documentation management systems and change control processes
  • Carrying out internal audits
  • Carrying out training to SOPs
  • Critical review of CAPA / non-conformances / deviations / OOS
  • Conducting final batch release
  • Involvement in supplier quality processes
  • Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products
  • Customer complaints or technical support experience

• • Excellent team working skills
  • Ability to critically review documentation
  • Methodical, process orientated and highly organised
  • Excellent attention to detail
  • Excellent time management skills
  • Excellent verbal and written communication skills in English
  • Problem solving ability
  • Flexible with a can-do attitude
  • Willing to travel on an ad-hoc basis

• Competitive base salary and annual salary reviews.
• A comprehensive benefits package including Bupa health and dental cover, Life Assurance, Long-term Absence Cover and Cycle to Work Scheme.
• Participation in a competitive pension scheme starting at 2% employee contribution, matched by 7% employer contribution; up to 6% employee contribution and 9% employer contribution.
• Training support as required.
• 25 days annual leave.
• 37.5 hours working week with core hours of 10am-12pm and 2-4pm.

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