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Qualification Expert
vor 2 Wochen
Ihre Aufgaben:
- 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
Ihr 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
- Experience with Siemens COMOS, EVAL and VIVA is a plus
- 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
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