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Quality Assurance Lead Auditor

2 months ago

Wigston Magna, Leicestershire, United Kingdom Inizio Full time

Company Overview

Inizio Engage is a leading provider of innovative solutions in the pharmaceutical and biotechnology industries.

Job Summary

We are seeking an experienced Quality Assurance Lead Auditor to join our team. As a key member of our QA team, you will be responsible for managing our audit schedule, training internal auditors, and generating and reviewing SOPs.

Key Responsibilities:

  • Manage the audit schedule and ensure timely completion of internal audits and self-inspections.
  • Train internal auditors or arrange appropriate training to ensure compliance with industry standards.
  • Develop and review SOPs relevant to the position, ensuring alignment with industry best practices.
  • Manage QPulse, our audit management system, to schedule and track audit non-conformances.

Requirements:

  • Proven track record of QA internal/external auditing in the pharmaceutical or biotechnology industry.
  • Lead auditor experience in GMP areas, with a strong understanding of FDA, MHRA, and other regulatory agencies.
  • Excellent communication and leadership skills, with the ability to train and mentor internal auditors.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development in a dynamic and innovative company.
  • A collaborative and supportive work environment.

How to Apply:

Please submit your application, including your resume and a cover letter, to us. We look forward to hearing from you.