For one of our Clients, a company based in Kaiseraugst, we are looking for aQualification Expert.
The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably the pharmaceutical industry.
General Information:
* Start date: ASAP
* Planned duration: 12 months
* Extension: possible
* Workplace: Kaiseraugst
* Workload: 100%
* Remote/Home Office: max. 20%
* Travel: no
* Team: 10 people
* Working hours: Standard
Tasks & Responsibilities:
* 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
Must Haves:
* Technical degree or relevant work experience in qualification with GMP
* 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 is a must
* Experience with Siemens COMOS, EVAL and VIVA is a plus
* 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-organised teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
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