SIRE Life Sciences®

Validation Expert

Location: Netherlands

SIRE 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 Netherlands.

This organisation is a market leader that offers services for both the pharmaceutical and medical device sector. They support customers in the development and manufacturing of high technology and innovative products. They are experiencing a continuous growth and therefore, they are looking for the right support.

ROLE DESCRIPTION

You will become part of an ambitious environment where they are focused on high-technology products. In your role as validation specialist, you will be responsible for the validation and control of certain procedures for which you are making sure that the product specifications and developments are compliant in relation to relevant documentation. You will be in contact with other locations of the organisation within Europe. Furthermore, you are involved in the development of trainings and you will report directly to the QA manager. This project is set for a period of 5 months and can be extended to 7 months or more.

RESPONSIBILITIES

You will be responsible for validation management where you will be coordinating the QA department. Further responsibilities involve:
• Keeping on track with required and relevant documentation in relation to the product specifications
• Taking the lead in risk management procedures
• Development of trainings and creating tools for execution
• Contact person for various locations regarding quality and validation topics
• Making reports including points of improvements and creating action tools

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 6 years of experience within the Medical Device industry in a QA role
• Broad knowledge of international Medical Device regulations
• Excellent knowledge of ISO 13485, risk management and validation management
• Great knowledge of Good Manufacturing Practice and GAMP
• Experience with the implementation and improvement of Quality Management Systems
• Team player and strong communicator
• Excellent organisational and analytical skills

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.

Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
SIRE Life Sciences®

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