23 days ago on sire-search.com

Computer System Validation Manager

SIRE Life Sciences

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Computer System Validation Manager

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!


Our client is a professional Biotechnology, Medical Devices and Pharmaceutical organization, based in Basel-Stadt Switzerland.

Our client is a Pharma & BioTech organization in Basel


- Responsible for Validation & Qualification of Equipment and Computerized Systems according to 21 CFR part 11, EU-GMP, GLP and other relevant guidelines


- Responsible for set up of Validation & Qualification documents in cooperation with QA department
- Set-up of SOP's for this area
- Responsible for technical documentation such as Change Control etc for Computerized Systems
- Training and consulting of employees with regards to computerized system compliance
- Preparation of Internal and External audits


- At least 2 years experience in validation of computerized systems (CSV)
- Experience with 21 CFR Part 11
- Ideally experience with QMS for GLP / GMP / ISO9001
- Basic IT Knowledge
- Fluency in English and ideally also German

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.