Quality Assurance Manager

2 days ago


Westmeath, Ireland FRS Recruitment Full time
Job Description

We are seeking an experienced Quality Assurance Manager to oversee the QC analytical team in a biopharmaceutical environment. This role will ensure that laboratory operations comply with global regulatory standards, drive continuous improvement, and support audit readiness.

Main Responsibilities
  • Lead and manage a QC analytical team, ensuring all testing activities comply with GMP regulations.
  • Oversee stability testing, ensuring results are accurate and delivered on time.
  • Maintain an inspection-ready QC laboratory and ensure compliance with data integrity guidelines.
  • Manage the laboratory schedule to optimize resources and meet business deadlines.
  • Investigate quality events, deviations, and out-of-specification (OOS) results, ensuring timely resolution.
  • Support the development and validation of analytical methods for routine testing.
  • Ensure all team members are appropriately trained and maintain high documentation standards.
  • Contribute to continuous improvement initiatives to enhance quality and efficiency.
Requirements
  • Significant experience in a QC leadership role within a GMP-regulated biopharmaceutical or pharmaceutical environment.
  • Stability/QC/analytical R&D/project and program management.
  • Direct supervision of technical staff.
  • Full understanding of GMP requirements
  • Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, i CE, SDS-PAGE), ELISA, spectrophotometry.


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