Qualification Expert (m/f/d)

• Start date: ASAP
• Latest possible start date: 01.12.2025
• Duration: 12 months, with the possibility of extension
• Workplace: Kaiseraugst
• Home office: up to 20%
• Workload: preferrably 100%, 80-100% possible

Tasks & Responsibilities:
 

• Planning and implementation of qualification activities for existing production systems and facilities (e.g., sterile filling systems, assembly systems, packaging lines, freeze dryers, clean rooms, cold rooms, and media)
• Creation and maintenance of qualification documentation (plans and reports)
• Analysis and processing of deviations: Conducting root cause analyses
• Preparation of technical impact assessments and development of proposed solutions.
• Support in the implementation of new processes and systems as well as continuous process improvements
• Close collaboration with operations, quality assurance, and other interfaces
• Development, implementation, and execution of test strategies, test plans, and test cases to verify system performance and compliance.
• Actively contribute to and promote collaboration within a dedicated team of experts through a proactive, solution-oriented, and reflective approach

Must Haves:
 

• Degree in a natural sciences/engineering program or relevant professional experience
• At least 1-3 years of professional experience and solid experience in the qualification process
• Practical professional experience with the qualification of various types of systems and rooms/media
• Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements
• Initial contact with the topic of data integrity is desirable
• Very good written and spoken English and German skills
• Highly independent and structured working style with the commitment to continuously improving oneself and processes
• High degree of initiative, flexibility, and quick comprehension
• You are characterized by a solution-oriented approach and are able to find practical solutions even in complex situations.
• Team spirit, enthusiasm for cross-functional collaboration, and the ability to actively contribute to a positive working environment.