GLP Quality Assurance Specialist

2 weeks ago

Newry, United Kingdom MCS Group Full time
GLP Quality Assurance Inspector Job Description

MCS Group is proud to be working with a leading global pharmaceutical company to recruit a GLP Quality Assurance Inspector to join their growing team.

Key Responsibilities:
  • Conduct inspections and generate audit reports within the R&D GLP Division to ensure compliance with GLP Guidelines.
  • Assist in the upkeep of a current and effective QMS in accordance with Regulatory Authority requirements and company standards.
  • Perform live phase and data inspection of the various GLP sections (Laboratories, test article facility, data analysis, study management, archive facility) for compliance with international GLP guidelines.
  • Generate deficiency reports, notify relevant parties including QA and Test Facility management of inspection findings and recommended actions.
  • Assist in the upkeep of the GLP Change Control, deviations, CAPA and Laboratory Investigations databases to contribute to the continued development, performance and compliance of the GLP section and quality of new product development and life cycle management.
  • Contribute effectively to the regular, documented Quality review process, that includes a review of quality performance versus key quality metrics/ KPIs for all key elements of the PQS.
  • Ensure critical phases, data and reports are audited, and findings reported as per house SOPs.
  • Conduct of facility audits of the GLP facilities
Requirements:
  • Educated to degree level in a relevant life science related discipline or a minimum of 2 years relevant experience working within a GLP or GMP environment.
  • Laboratory experience, including reviewing data using Empower (CDS)
  • Experience in maintenance and trending of deviation and laboratory investigation systems.
  • Experience in managing change control
  • Ability to read and interpret laboratory procedures, methods and data, GLP and regulatory guidance.
  • 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
  • Demonstrated experience in a clinical setting, working on clinical and non-clinical studies operating to GLP

MCS Group offers a competitive salary (DOE), subsidised canteen, discount on car insurance, 32 days of Annual Leave, Life Assurance, Company Pension Scheme, Health care, Cash Plan, Development and growth opportunities, On-site free car parking, and many more benefits.

To speak in absolute confidence about this opportunity, please send an up to date CV via the link provided or contact Amy Wallace, Specialist Consultant at MCS Group.

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