GLP Quality Assurance Specialist

2 weeks ago

Newry, United Kingdom CPL Full time
Job Title: GLP Quality Assurance Specialist

We are seeking a highly skilled GLP Quality Assurance Specialist to join our team at CPL, a globally recognized pharmaceutical company. As a GLP Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our veterinary medicines.

Key Responsibilities:
  • Perform live phase and data inspections of GLP sections for compliance with International GLP Guidelines
  • Generate deficiency reports and notify relevant parties of inspection findings and recommended actions
  • Assist in the upkeep of GLP Change Control, Deviations, CAPA, and Laboratory Investigations databases
  • Contribute to the regular Quality review process, including a review of Quality performance versus key Quality metrics/KPIs
  • Conduct facility audits of GLP facilities and ensure critical phases, data, and reports are audited and findings reported
Requirements:
  • Education to degree level in a relevant life science related discipline or a minimum of two years relevant experience working within a GLP or GMP environment
  • Previous laboratory experience, including reviewing data using Empower (CDS)
  • Experience in maintenance and trending of deviation and laboratory Investigation systems
  • Experience in managing Change Control
  • Demonstrable experience in a Clinical setting working on clinical and non-clinical studies operating to GLP
Desirable Criteria:
  • Experience working in a QA function in a GLP or GMP environment
  • Experience in the approval, introduction, and control of study and facility related documentation
  • Experience developing and maintenance of Excel spreadsheets for tracking purposes
  • Understanding of bio-analysis
  • Knowledge of FDA/EMA practices and guidelines

If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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