Senior Quality Compliance Analyst

Through acquisitions and mergers, this leading global biopharmaceutical organisation have expanded rapidly in their short history. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to serve significant unmet patient needs. They are now seeking a Senior Quality Compliance Analyst to join their team.

The Role:

Reporting into the QA Associate Director you will be part of a fast paced project team where you will work with minimal supervision and be committed to quality results and strict compliance with regulatory standards. This role is a 12 month contract. Your key responsibilities as Senior Quality Compliance Analyst will include:

Key Responsibilities:

  • QA guidance and oversight for the validation of equipment and facility upgrades
  • Development of cross contamination control strategy to support the multiproduct licence for a new facility
  • Provide commercialisation support from a quality perspective
  • Review and approval of validation SDLC documents for equipment upgrades
  • Provide quality guidance and support for licensure of Biologic products
  • Quality and regulatory review of documentation supporting regulatory submissions

The Person:

The successful Senior Quality Compliance Analyst should possess:

  • BSc in Science or a releated degree
  • 5 years’ experience in a quality discpline within the Pharmaceutical or Medical Device industry
  • Strong regulatory knowledge and working within regulated environments
  • QP status or qualification

To learn more apply online or contact Orla Boyle at HRM directly on +353 91 782110 for a confidential chat.

Salary: €45000 - €45000 Location: Mayo