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Qualification Manager (m/w/d)

Skan AG

Employment type
Full-time
Location
Allschwil
First posted
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  Founded in 1968, SKAN is one of the pioneer companies in the specialist areas of cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, customer-specific solutions, and a powerful service and support organization have made SKAN a market leader and an important partner for industry and research laboratories.     At a glance   In our young Qualification Management team, we are looking for reinforcement with an affinity for technology, documents, an eye for detail, and a very high quality standard. We operate in the pharmaceutical environment and are therefore required to comply with strict regulations. The team prepares test protocols, actively accompanies their execution on our highly complex isolator systems, and evaluates the resulting reports for technical release. In doing so, the scope extends from internal conformity testing to customer-side qualification (IQ/OQ). Working with specifications, assessment matrices, and work instructions, as well as interdisciplinary and international cooperation, are part of the typical daily routine. Continuous internal exchange, as well as enjoyment of customer-oriented project work, is very important to us in order to constantly stay one step ahead together.     Tasks   • Responsible for the planning and implementation of qualification measures in accordance with applicable regulations (e.g., GMP, ISO, MRL) for customer projects, maintenance, as well as annual requalifications • Coordination of the qualification strategy with customers • Creation of project-specific test protocols (such as IQ and OQ) • Technical assessment of test reports • Analysis and evaluation of process and plant data for quality control • Implementation of specialist training, such as GMP-compliant documentation • Interface to various departments     Hardskills   • University or technical college degree in engineering or natural sciences • Preferably experience in a GMP environment (ideally in qualification) or in quality management • Solid knowledge of MS-Office • Business fluent in German and English     Softskills   • Solution-oriented thinking • High quality standards • Responsible, careful, and cleanly documented way of working • Open communication and enjoyment of teamwork • Competent and professional appearance towards customers • Coordination and organizational skills • Willingness to travel (up to approx. 10%)     We offer   • An open and collegial corporate culture • Freedom for ideas • Participation in sports and leisure activities • Support through further training, especially at our SKAN Academy • Intensive and job-oriented induction • Short decision-making paths and flat hierarchies • Open communication policy • 5 weeks vacation and the possibility of additional vacation days     Further information   We look forward to receiving your complete application documents (CV, diplomas, and work certificates), which you can submit directly via our career page. For this vacancy, we rely on direct applications and do not work with external agencies. Submitted dossiers from agencies will not be processed.   If you have any questions, please contact Viviane Braxton.

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Posted 3 days ago

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