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Quality Specialist - Audit Management

Quality Auditor

Ready to move into your next role as a Quality Auditor? Look no further, this is the job for you! This is a permanent position and with remote working options. The successful candidate will be part of the Development & External QA Operations group.

Responsibilities

  • Develop and manage the Clinical Phase and Commercial Contractor Quality Management Program
  • Develop and Manage the internal auditing program for External Operations
  • Manage additional auditing personnel and perform vendor audits, and other qualification activities
  • Management and maintenance of the contractor and clinical phase suppliers GMP Approved Supplier List including the audit schedule
  • Support of Quality/Technical Agreements, External Service Agreements
  • Auditor training with a focus in data integrity auditing; qualifying auditors and SMEs for external auditing
  • Troubleshoot issues, develop and implement effective risk mitigation strategies as required

Experience required

  • 8+ years’ experience in a Quality Assurance role
  • Certified Quality Auditor is advantageous
  • Expert knowledge on regulatory requirements and industry expectations for Vendor / supplier Quality Management
  • Working knowledge of US and European Drug Product GMP requirements

*Ability to travel up to 40% of the time*

The Next Step for you:

Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button!

Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there.

Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT.

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