Senior Quality Assurance Analyst

3 days ago

Haverhill, Suffolk, United Kingdom Euroapi Full time

Job Summary

We are seeking a highly skilled Senior Quality Assurance Analyst to join our Quality Control Technical Services Team on a contract basis. As a Senior Quality Assurance Analyst, you will be responsible for ensuring the highest pharmaceutical regulatory and compliance standards are met in the production of active pharmaceutical ingredients.

Key Responsibilities

  • Ensure effective troubleshooting of equipment or technique failures and troubleshooting of problems associated with various analytical techniques.
  • Sample, analyze, and release API, drug products, test incoming raw materials and drug packaging, provide import testing for drug product batches, CDMO batch testing, In-process samples, cleaning validation, verification analysis, and batch release for raw materials.
  • Write, review, and drive the completion of validation/analytical transfer activities, owning your analytical projects within the team.
  • Develop, train, and report validation and transfer activities within QC for new and existing clients.
  • Perform effective reactive and proactive investigations, driving continuous improvements.
  • Drive compliance working with QA and promote quality standards.
  • Research, develop, train, and report validation and transfer activities within QC for new and existing clients.
  • Ensure that departmental objectives are implemented in line with the overall Quality/Corporate goals.
  • Comply with all safety and GMP requirements within the Laboratory.
  • Document all testing activities to regulatory standards.
  • Participate in and facilitate improvement programs within the Laboratory.
  • Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with the client's values.
  • Complete additional tasks considered necessary to meet business and customer requirements as indicated by the team leader.

About Euroapi

Euroapi is a leading player in active pharmaceutical ingredients with a portfolio of approximately 200 products. We offer a wide range of technologies and develop innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities. Our company is focused on reinventing active ingredient solutions to sustainably meet customers' and patients' needs around the world.

Requirements

  • Sciences degree.
  • Proven pharmaceutical experience handling HPLC, GC FTIR, UV, PXRD, DSC.
  • GMP knowledge coupled with proven experience of analytical method validation & transfer principles.

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