Internal & external auditor professional
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
This organisation focuses on the improvement of international healthcare. This market leader offers a broad range of products for the healthcare sector. This organisation is experiencing a rapid growth and are therefore looking to expand their capacities across the globe.
ROLE DESCRIPTION
Quality in this organisation is set at a high standard. You will get a flexible and dynamic position within the organisation. You will have an advisory role in which you travel frequently to various business sites across Europe. Furthermore, you will take the lead for GMP audits both with internal and external stakeholders. You will maintain relationships with the various stakeholders at the site. This includes collecting and organizing required documentation, consistently reporting all points of improvements and developments, and finally checking the coherence between the product specifications and international legislation. This project is set for 3 months with additionally 3 months of possible extension.
RESPONSIBILITIES
You will be in charge of the required documentation, planning and execution. Next to that, other major tasks involve:
• Major point of contact regarding audits for internal and external stakeholders
• Planning and organisation of internal and external audits, which involves our guidance throughout the entire process
• Keep on track with the changes and developments within the industry, including relevant legislation and regulations on an international scale
• Maintenance of relationships involving internal and external stakeholders among which departments across the organisation, notified bodies, and other
authorities
• Assessment and identifying points of improvement from reports conducted during audits
REQUIREMENTS
• Master in Life Sciences
• Minimal 4 years of experience as auditor within Medical Device company
• Excellent knowledge of FDA and European standards
• Excellent knowledge of Lean six-sigma procedures
• Strategic planning and organisation skills
• Proven evidence of addressing changes and assessment of QMS
• Strong communicator
• Pro-active and flexible attitude
• Fluency in English and Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.
