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Validation and Compliance Expert

2 months ago

Haverhill, Suffolk, United Kingdom EUROAPI Full time

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our global quality team at EUROAPI. As a Senior Quality Assurance Specialist, you will be responsible for providing active ingredients that meet the highest pharmaceutical regulatory and compliance standards.

Key Responsibilities

  • Owns analytical projects and deputizes for leadership, working with R&D, clients, and key stakeholders.
  • Works with quality management team to assign and manage project resourcing.
  • 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 and sharing best practices within the group.
  • Develop, train, and report validation and transfer activities within quality for new and existing clients.
  • Lead effective reactive and proactive investigations, driving continuous improvements.
  • Drive compliance working with quality assurance and promote quality standards.
  • Research, develop, train, and report validation and transfer activities within quality for new and existing clients.
  • Ensure effective troubleshooting of equipment or technique failures and troubleshooting of problems associated with various analytical techniques.
  • Sample, analyze, and release drug products, test incoming raw materials and drug packaging, provide import testing for drug product batches, CDMO batch testing, 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.

About EUROAPI

EUROAPI is a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

We are a global company with a strong research and development capabilities and six manufacturing sites all located in Europe. Our company ensures API manufacturing of the highest quality to supply customers in more than 80 countries.

Requirements

  • Sciences degree.
  • A high level of pharmaceutical experience handling HPLC, GC, FTIR, UV, PXRD, DSC.
  • GMP knowledge coupled with proven experience of analytical method validation & transfer principles.
  • Experience of deputizing for senior leadership and working closely with R&D, clients, and key stakeholders to manage key analytical projects.

What We Offer

  • Competitive hourly rate and retention bonus.
  • Training & development.
  • A quick turnaround with two interviews and flexibility to offer a quick start date.
  • 23 months contract term.
  • 36 hours per week, Monday-Thursday 9-5.30pm, Friday 9-4pm.