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Senior Validation Specialist
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 Medical Devices and Pharmaceutical organization, based in Waadt Switzerland.
My client is a fast-growing Medical Devices company near Zurich. They concentrate on customised injection devices for drug delivery. They are ISO 13485 and 9001 certified, and work on the basis of FDA 21CFR part 820.
Your position will be key in making sure the correct validation and verification strategy is being performed. Because of the fact that a large part of the company is outsourced, including most of the production and testing, you will have to make sure that the correct validation plans are being followed by the third parties. Because of the urgency, they are now looking for a freelancer and/or consultant to help them out and set out the right strategy. For this project, there is budget until the begin of 2016, but with a strong possibility for an extension into the Q2 2016.
- Development of Validation concepts
- Organising and planning of revalidation of processes and computer guided systems
- Development of validation plans on the basis of statistics
-Tracking the fulfilment of validation plans
- GMP documentation in validation protocols
- External validation process control
- Spokesperson for Qualification / Validation at Audits
- Co-worker in the Quality Department
- Experience in manufacturing of Medical Devices
- Knowledge of GMP and RA in the manufacturing and control of medical devices, including statistical knowledge and FMEA
- Extensive experience in qualification and validation in Medical Devices and the clean room technology
- Degree in engineering
- Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.