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Wigston Magna, Leicestershire, United Kingdom Inizio Engage Full timeQuality Assurance Lead Auditor OpportunityInizio 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...
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Lead Auditor for QA and Compliance
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Lead Auditor for QA and Compliance
2 months ago
Wigston Magna, Leicestershire, United Kingdom Inizio Engage Full timeInizio 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...
Quality Assurance Lead Auditor
2 months ago
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.