Senior Quality Associate

3 weeks ago


London, Greater London, United Kingdom Vertex Pharmaceuticals Full time
Job Summary

Vertex Pharmaceuticals is seeking a Senior Quality Associate to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our pharmaceutical products.

Key Responsibilities:

  1. Perform disposition activities for Finished Goods in support of Clinical/Commercial Product.
  2. Review and resolve comments/issues on Master and Executed Batch Records.
  3. Evaluate Investigations/OOS/Change Controls to support Disposition Status.
  4. Approve Certificate of Analysis.
  5. Update Status in Oracle.
  6. Archive batch documents in electronic document system.
  7. Collaborate with internal teams to review and approve procedures.
  8. Provide quality guidance for root-cause analysis and product impact assessment for investigations.
  9. Support quality oversight of artwork/label review, approval, and implementation.
  10. Develop relationships with external partners to support Vertex's commercial portfolio.

Requirements:

  1. Relevant degree.
  2. Good communication skills and ability to engage with internal and external stakeholders.
  3. Demonstrated ability to work independently to provide QA support for relevant projects.
  4. Skilled in creating and maintaining spreadsheets in Excel.
  5. Knowledge of global GMP/GDP requirements governing oral drug products.
  6. Knowledge of packaging and labeling process and artwork requirements.
  7. Investigation and Root Cause Analysis tools/methodology.
  8. Audit process understanding.

Flex Designation:

This role is eligible for Vertex's Flex @ Vertex Program, allowing you to choose between Hybrid or On-Site work arrangements.

Company Information:

Vertex Pharmaceuticals is a global biotechnology company committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.



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