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Our client is a professional Medical Devices organization, based in Sankt Gallen Switzerland.
A internationally renowned company in the production of packaging for pharmaceuticals. The company works according to both ISO and GMP regulations.
Because of a maternity leave, my client is looking for an ad interim validation specialist for 12 months. The project will start at November the 1st. For the first two months, the position can be 50% (but up to 100% if you as a consultant have the spare time available). In these two months, you will have the time for getting acquainted with the company, the team and the processes. Afterwards, you will be expected to work for 100%.
Your main focus will be in the validation of the processes and the equipment. Your main project next to this will be the setting up of a validation master plan for the whole site. This is because the company wants to go to a more strategic approach regarding continuous improvement, instead of short-term fixes. This work will be done in a project team, but as responsible person for all validation on the site, your input will be key to setting up this plan.
- Be responsible for all validation and verification of equipment and processes
- From a Risk Management perspective working towards the validation, verification and qualification.
- Work together with the responsible project leaders for all V&V projects
- Release of all documents related to validation, verification and qualification
- Expert for setting up the site validation master plan
- Make sure that the correct documents are being released during audits
- Education and training of all production floor personell
- 5-7 years of minimum experience in process and equipment validation, verification and qualification in the pharmaceutical or medical devices sector
- ISO 9001 or GMP knowledge
- Experience in setting up site validation master plans
- Self driven person, have to be able to work on your own
- Fluent in German (or at least fluent in speaking and reading)
- 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.