Qualification Expert (m/f/d)
EINFÜHRUNG :
As a preferred supplier for F. Hoffmann - La Roche Ltd. in Basel, we are looking for a motivated
Qualification Expert (m / f / d) 100%
This is a full-time position, with a one-year duration and possible extension. The earliest start date is as soon as possible and the latest in August 2024.
Home Office : max. 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 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
Application process
Interested? You can find more information here :
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