QA GLP Inspector

Employer Information

Norbrook

E: human.resources@norbrook.co.uk

T: + 44 (0)28 3026 4435

W:

Working within the R&D Department and reporting to the GLP QA Manager, the QA inspector will be responsible for conducting inspections within the GLP Division of R&D to ensure compliance with GLP and other relevant regulatory guidance. The successful candidate will generate audit reports and assist in the upkeep of the GLP Quality Management system.

Main Activities/Tasks

  • Perform live phase and data inspections of the various GLP sections (laboratories, animal facility, test article facility, data analysis, study management, archive facility) for compliance.
  • Generate deficiency reports, notify relevant parties including QA and Test Facility Management of inspection findings and recommended actions.
  • Assist in the upkeep of GLP Change control, Deviations, CAPA and Laboratory investigations databases to contribute to continued development, performance and compliance of the GLP section and quality of new product development and life cycle management.
  • Contribute effectively to regular, documented Quality review process, that includes a review of Quality performance versus key Quality metrics/KPIs, for all key elements of the PQS including:
  • Service Level Agreements with the CROs as applicable
  • Document Control, Retention & IT Systems
  • Review and trending of Deviations and Laboratory investigations
  • Review and tracking of CAPAs
  • Clinical Facilities and Study Audit Program
  • Change Management
  • Conduct of facility audits of GLP facilities.
  • Ensure critical phases, data and reports are audited and findings reported as per in house SOPs.
  • Assist in the control/reconciliation of controlled study and facility documents.
  • Maintain awareness of current national and international regulations and requirements for GLP and GCP and other relevant quality standards.

Essential Criteria:

  • Educated to degree level in a relevant life science related discipline OR a minimum of two years’ experience working in a GLP or GMP environment (full training will be provided)
  • Experience in maintenance and trending of deviation and laboratory investigation systems
  • Experience in managing Change Control
  • Demonstrate the ability to read and interpret laboratory procedures, methods and data, GLP and regulatory guidance
  • Strong attention to detail
  • Excellent organisation and communication skills (written and verbal) across a range of interdepartmental levels
  • Demonstrate the ability to work independently on assigned responsibilities as well as part of a team to a high standard to meet deadlines.
  • A full driving licence is required

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
  • Demonstrable experience in a Clinical setting (in-house and/or CROs etc.) working on clinical & non clinical studies operating to GLP
  • Understanding of Good Laboratory Practice principles and standards, and quality management systems
  • Knowledge of FDA/EMA practices and guidelines
  • Experience in the trending and interpretation of analytical data
  • Experience of preparing responses to regulatory queries

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy we would particularly like to welcome applicants from the Protestant Community.

 

  • Permanent
  • Newry
  • Closing date: Wednesday 30 Nov 2022
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