Quality Assurance Lead Auditor

2 months ago

Wigston Magna, Leicestershire, United Kingdom Inizio Engage Full time

Inizio Engage is pleased to announce a new opportunity for a Quality Assurance Lead Auditor to join their team. This role is a fantastic chance to be part of a growing business and contribute to the development of their corporate audit team.

The ideal candidate will have a proven track record of QA internal/ external auditing, with experience in the pharmaceutical or biotechnology industry. Lead auditor experience in GMP areas and inspection experience with FDA, MHRA and other agencies are highly desirable.

The successful candidate will be responsible for managing the audit schedule, training internal auditors, and generating, reviewing and approving SOPs relevant to the position. They will also be responsible for managing QPulse relating to audits, including audit scheduling and management of audit non-conformances on the system.

Key Responsibilities:
  1. Manage the audit schedule to ensure timely completion of internal audits and self-inspections.
  2. Train internal auditors or arrange appropriate training to ensure they have the necessary skills and knowledge to complete audits to schedule.
  3. Generate, review and approve SOPs relevant to the position, ensuring they are up-to-date and compliant with regulatory requirements.
  4. Manage QPulse relating to audits, including audit scheduling and management of audit non-conformances on the system.
Key Skills:
  1. Proven track record of QA internal/ external auditing, with experience in the pharmaceutical or biotechnology industry.
  2. Lead auditor experience in GMP areas.
  3. Inspection experience with FDA, MHRA and other agencies.

Inizio Engage is a dynamic and growing business, and this role offers a unique opportunity to be part of their team and contribute to their success.

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