GLP Quality Assurance Inspector

2 weeks ago

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

We are seeking a highly skilled and experienced GLP Quality Assurance Inspector to join our team at CPL. As a GLP Quality Assurance Inspector, you will be responsible for ensuring the quality and integrity of our products and processes.

Key Responsibilities:
  • Perform live phase and data inspections of various 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 the GLP Change Control, Deviations, CAPA, and Laboratory Investigations databases
  • Contribute to the regular, documented 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 as per in-house SOPs
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 (in-house and/or CROs etc.,) 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
  • Knowledge of Pharmacovigilance (PV) guidelines and previous experience of conducting PV audits

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