quality manager/ qualified person
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 Biotechnology and Pharmaceutical organization, based in Noord-Holland Netherlands.
It’s an unique organization, nowhere else in the world is medical, pharmaceutical and scientific knowledge combined into one innovative company. It’s a dynamic organization combining medical, pharmaceutical and diagnostic knowledge into one company.
ROLE DESCRIPTION
Are you good at working together across the boundaries of your own department and easily build and maintain contacts? Are you able to contribute to the next level of our quality systems required for the preparation and release of laboratory reagents? Are you a natural leader with conviction that can properly utilize the years of experience present at the QA / QC department? Then this is the job for you! It’s a position for at 6 months with possibility to extend.
RESPONSIBILITIES
You will responsible for managing the QA / QC department as well as taking account and monitoring quality systems and actively contributing to improvements and process optimization / process validations. Next to that you will be responsible for the following:
- Compiling, modifying and / or evaluating the necessary documentation (SOPs)
- Evaluating whether procedures comply with applicable laws and regulations in collaboration with other disciplines and departments
- You are a Qualified Person under the EU CE-IVD Legislation, and be responsible for the regulatory compliance of the organization, documentation, declaration of conformity, performance evaluations and vigilance
REQUIREMENTS
- Msc degree biotechnology or pharmaceutical industry
- Minimum 5 year international experience in manager QA/QC
- Knowledge about the ISO13485 and ISO9001
- Experience with QMS is a plus
- Experience with implementing quality improvements
- Experience with product registrations
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
