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Quality Assurance Lead Auditor

2 months ago


Wigston Magna, Leicestershire, United Kingdom Inizio Full time

About Inizio Engage

Inizio Engage is a leading contract research organization involved in the development, manufacture, and testing of pharmaceutical and biotechnology products and medical devices.

We are seeking an experienced Quality Assurance Lead Auditor to join our QA team as a leader for our auditing requirements. This is a new role that will be the start of our client developing its own corporate audit team.

Key Responsibilities:

  • Manage our clients audit schedule
  • Train internal auditors or arrange appropriate training to ensure internal audits/self-inspections are completed to schedule
  • Generate, review, and approve SOPs relevant to the position
  • Manage QPulse relating to audits - audit scheduling and management of audit non-conformances on the system

Key Skills:

  • Proven track record of QA internal/external auditing, pharmaceutical or biotechnology industry
  • Lead auditor experience in GMP areas
  • Inspection experience with FDA, MHRA, and other agencies

About the Role

This is a fantastic opportunity to join a growing business, in a newly created role, and to create your own audit team. As a Quality Assurance Lead Auditor, you will be responsible for managing our clients audit schedule, training internal auditors, and generating SOPs relevant to the position.

What We Offer

We offer a competitive salary and a chance to work with a leading contract research organization in the pharmaceutical and biotechnology industry.