Qualification Manager

vor 3 Wochen

Allschwil, Schweiz SKAN AG Vollzeit

Overview

We are looking to strengthen our young Qualification Management team with an affinity for technology, documents, an eye for detail and 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 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.

 

Responsibilities

  • Responsible for the planning and implementation of qualification measures in accordance with the applicable regulations (GMP, 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
  • Analysing and evaluating process and system data for quality control purposes
  • Carrying out specialised training courses, such as GMP-compliant documentation
  • Interface to various departments

 

Hardskills

  • University or university of applied sciences degree in natural sciences or engineering 
  • 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 organisational skills
  • Willingness to travel (up to approx. 10%)

 

We offer you

  • An open and collegial corporate culture
  • Freedom for ideas
  • Participation in sports and leisure activities
  • Promotion through further training, especially at our SKAN Academy
  • Intensive and job-oriented introduction
  • Short decision-making paths and flat hierarchies
  • Open communication policy
  • 5 weeks holidays and the possibility of further holidays

 

For questions please contact Luca Waldner


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