GLP Quality Assurance Inspector

MCS Group is proud to be working with one of the top 20 global pharmaceutical companies, to recruit a GLP Quality Assurance Inspector to join their growing team.

As a GLP QA Inspector you will be responsible for conducting inspections and generating audit reports within the R&D GLP Division to ensure compliance with GLP Guidelines. You will assist in the upkeep of a current and effective QMS in accordance with Regulatory Authority requirements and company standards.

You will.

• 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
• Assist in the control/reconciliation of controlled study and facility documents

Essential 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. (Full training will be provided)
• 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

What's in it for you?

• 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
  Full details will be provided upon application.

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 028 9049 0898

Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs

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