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Quality Assurance Lead Auditor

2 months ago

Wigston Magna, Leicestershire, United Kingdom Inizio Engage Full time
Quality Assurance Lead Auditor Opportunity

Inizio Engage is proud to present a unique opportunity for a seasoned Quality Assurance Lead Auditor to join one of the UK's fastest-growing privately owned businesses in the pharmaceutical and biotechnology industry.

This is a newly created role that will enable the successful candidate to establish and lead the company's audit team, driving quality and compliance across the organization.

Key Responsibilities:
  1. Develop and implement an audit schedule to ensure compliance with regulatory requirements
  2. Train and mentor internal auditors to ensure effective self-inspections and audits
  3. Develop and review Standard Operating Procedures (SOPs) relevant to the position
  4. Manage QPulse, the company's audit management system, to schedule and track audits and non-conformances
Key Skills and Experience:
  1. Proven track record of QA internal and external auditing in the pharmaceutical or biotechnology industry
  2. Lead auditor experience in GMP areas, with a strong understanding of regulatory requirements
  3. Inspection experience with FDA, MHRA, and other regulatory agencies

Inizio Engage is committed to providing a supportive and challenging environment for our employees. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application.