EINFÜHRUNG:
As a preferred supplier for Roche Basel in Kaiseraugst, we are looking for an individual
Qualification Expert
This is a full-time position (100%) with a 12-month contract. The ideal start date is asap. Home Office is possible up to 20%.
AUFGABENBESCHREIBUNG:
* Responsible for planning and conducting qualification and validation activities
* Creating and reviewing qualification and validation documents
* Producing SOPs and providing support in the creation of manufacturing specifications
* Responsible for maintaining the qualified and validated status of rooms, infrastructure and equipment
* Ensuring compliance with internal and external regulatory requirements with regard to qualification and validation
* Collaborating closely and communicating intensively with other departments
* Providing assistance in the processing of deviations, changes and CAPAs
ERFORDERLICHES PROFIL:
* Technical degree in a relevant field
* Further training and hands-on experience in the area of GMP
* Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
* Several years hands on work experience in qualification
* Experience with Siemens COMOS, EVAL and VIVA
* Fluency in German spoken and written needed, English fluency written and reading comprehension
* Very independent and structured way of working with a self-image of self and to continuously improve the processes
* High degree of initiative, flexibility and quick comprehension skills
* Enthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
Application process
Interested? You can find more information here: