Quality Assurance Specialist
vor 4 Wochen
Gi Group SA is seeking a highly experienced Qualification Expert to join our team.
Job Summary:We are looking for a skilled Qualification Expert to plan and conduct qualification and validation activities, create and review qualification and validation documents, and produce SOPs and manufacturing specifications. The ideal candidate will have several years of hands-on experience in qualification within a GMP environment, preferably in the pharmaceutical industry.
Key Responsibilities:- Plan and conduct qualification and validation activities
- Create and review qualification and validation documents
- Produce SOPs and manufacturing specifications
- Maintain the qualified and validated status of rooms, infrastructure, and equipment
- Ensure compliance with internal and external regulatory requirements
- Collaborate closely with other departments
- Provide assistance in the processing of deviations, changes, and CAPAs
- 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 of hands-on work experience in qualification
- Experience with Siemens COMOS, EVAL, and VIVA is a plus
- Independent and structured way of working with a self-image of self and to continuously improve 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 with a focus on the big picture
- Fluency in German spoken and written, English fluency written and reading comprehension
- Start date: ASAP
- End date: 1 year (extension possible)
- Work location: Kaiseraugst
- Remote/Home Office: 20% possible
- Workload: 100%
Please apply online. For further information about the position, please contact your Gi Group Recruiter, Fatbardha Igrishta.
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