Qualification Expert (m/f/d)

Jobdetails For our client, a leading international pharmaceutical company in Kaiseraugst, we are seeking a Qualification Expert.You will be part of a dynamic team working on innovative tasks at the interface between various production areas, including sterile filling, packaging, antibiotics, and solid dosage production. The working environment is characterized by close, cross-functional collaboration with colleagues. …The team is looking for multiple joiners and they can consider profiles of different level of seniority.General Information:Start date: ASAPLatest possible start date: 01.12.2025Duration: 12 months, with the possibility of extensionWorkplace: KaiseraugstHome office: up to 20%Workload: preferrably 100%, 80-100% possibleTasks & 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 analysesPreparation of technical impact assessments and development of proposed solutions.Support in the implementation of new processes and systems as well as continuous process improvementsClose collaboration with operations, quality assurance, and other interfacesDevelopment, 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 approachMust Haves: Degree in a natural sciences/engineering program or relevant professional experienceAt least 1-3 years of professional experience and solid experience in the qualification processPractical professional experience with the qualification of various types of systems and rooms/mediaSeveral years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirementsInitial contact with the topic of data integrity is desirableVery good written and spoken English and German skillsHighly independent and structured working style with the commitment to continuously improving oneself and processesHigh degree of initiative, flexibility, and quick comprehensionYou 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.mehr anzeigen For our client, a leading international pharmaceutical company in Kaiseraugst, we are seeking a Qualification Expert.You will be part of a dynamic team working on innovative tasks at the interface between various production areas, including sterile filling, packaging, antibiotics, and solid dosage production. The working environment is characterized by close, cross-functional collaboration with colleagues.The team is looking for multiple joiners and they can consider profiles of different level of seniority.General Information:Start date: ASAPLatest possible start date: 01.12.2025Duration: 12 months, with the possibility of extensionWorkplace: KaiseraugstHome office: up to 20%Workload: preferrably 100%, 80-100% possibleTasks & 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 analysesPreparation of technical impact assessments and development of proposed solutions.Support in the implementation of new processes and systems as well as continuous process improvementsClose collaboration with operations, quality assurance, and other interfacesDevelopment, 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 approachMust Haves: Degree in a natural sciences/engineering program or relevant professional experienceAt least 1-3 years of professional experience and solid experience in the qualification processPractical professional experience with the qualification of various types of systems and rooms/mediaSeveral years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirementsInitial contact with the topic of data integrity is desirableVery good written and spoken English and German skillsHighly independent and structured working style with the commitment to continuously improving oneself and processesHigh degree of initiative, flexibility, and quick comprehensionYou 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.mehr anzeigen