Qualification Manager - #53344

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organization have made SKAN a market leader and a key partner to industry and research laboratories.

Overview

We are looking to strengthen our young Qualification Management team with an affinity for technology, documents, an eye for detail and very high quality standards. We operate in the pharmaceutical environment and are therefore required to comply with strict regulations. The team creates test protocols, actively monitors their execution on our highly complex isolator systems and evaluates the resulting reports for technical approval. The scope ranges from internal conformity testing to customer qualification (IQ/OQ). Working with specifications, assessment matrices and work instructions is just as much a part of everyday life as interdisciplinary and international cooperation. Continuous internal dialogue and the joy of customer-oriented project work are very important to us in order to always be one step ahead together. You can look forward to a diverse and challenging range of responsibilities with a great deal of autonomy in a dynamic and international work environment!

Responsibilities

• Responsible for the planning and implementation of qualification measures in accordance with the applicable regulations (e.g. GMP, ISO, MRL) for customer projects, maintenance and annual requalifications
• Coordinating the qualification strategy with customers
• Preparation of project-specific test protocols (such as IQ and OQ)
• Technical assessment of test reports
• Analyzing and evaluating process and system data for quality control purposes
• Carrying out specialized training courses, such as GMP-compliant documentation
• Interface to various departments
  
  
  

Hardskills

• University or university of applied sciences 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-orientated thinking
• High quality standards
• Responsible, careful and well-documented way of working
• Open communication and enjoyment of teamwork
• Competent and professional demeanour towards customers
• Coordination and organizational skills
• Willingness to travel (up to approx. 10%)
  
  
  

We offer you

• An open and collaborative corporate culture
• Freedom to contribute and develop ideas
• Opportunities to participate in sports and social activities
• Professional development and continuous learning opportunities, especially at our SKAN Academy
• Comprehensive and career-focused onboarding
• Quick decision-making paths and flat hierarchies
• Transparent and open communication
• 5 weeks of vacation, with the option to take additional leave
  
  
  

Additional information

We look forward to receiving your complete application documents (CV, diplomas and employment references) via our career page.

For this position, we are focusing on direct applications and are not working with external agencies. Any dossiers submitted by agencies will not be processed.

For questions please contact Viviane Braxton.