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작업 내용

For a new and booming biotech company with unique product we are looking for a Site Lead Auditor. This is a broad role where you will be auditing internal and externally, do the audit planning and train, coach and help other staff with auditing. It concerns a unique product in biologics so it’s challenging and as it is a new company you will have a lot of influence on establishing processes in the light of audits. Last but not least, as it is a growing company there is a great outlook on future career development in the company.

Responsibilities:
Coordinate the entire GxP audit program, for both internal and external audits;
Carry out audits yourself and you will also be responsible for training and coaching all auditors;
Introducing more uniformity in the site audits;
Be responsible for the qualifications of the auditors and the continuous improvement of the audit program.
In a nice mix of independently and together, you work as the pivot around which the quality of our audit policy revolves. Without our Site Lead Auditor, we do not know whether the internal and external audits are performed optimally.
The position of Site Lead Auditor belongs to the QA Systems department. You report to the QA Systems manager and you also work closely with a group of lead and support auditors (approx. 15) from both the Quality unit and the rest of the organization. The QA Systems department currently consists of 11 (assistant) system officers. They are mainly involved in maintaining QMS, DMS and LMS and in addition with customer and supplier related activities such as quality agreements, supplier qualifications and complaint to vendor.

Requirements:
Minimum of HBO level;
Several years of relevant work experience in a cGMP environment, where you have gained extensive knowledge of audit methods and techniques, pharmaceutical laws and regulations and quality systems;
Certification as a Lead Auditor is a must;
Both Dutch and English language skills

Benefits:
Attractive salary;
28 vacation days per year;
Personal Development Budget to develop yourself on a professional level for which you can bring your own proposals;
Flexible hours;
The opportunity to join a promising company in the growing phase and develop yourself career wise;
If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop Consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!
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마감 시간: 31-12-2025

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