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Quality Control Qualification and Validation Specialist

Engineering
Bern
English


Do you have several years of experience in computerized system validation (CSV) in a GMP environment and good kledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)?
If your answer is yes, this opportunity is for you!

Main Responsibilities

  • Coordination of computerized system qualification and validation activities within the Quality Control department;
  • Define the validation strategy;
  • Perform and/or support the writing of specification documents (URS);
  • Review test protocols, plans and reports;
  • Support test execution;
  • Support and train team members in CSV methodology;
  • Supporting the timely and effective completion of investigations, change controls and CAPA’s;


Requirements

  • Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience;
  • Several years of experience in computerized system validation (CSV) in a GMP environment and good kledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...);
  • od understanding of analytical technologies;
  • Strong analytical thinking and problem-solving ability;
  • Excellent communication and teamwork skills;
  • Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly;
  • Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports;
  • Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines;
  • od verbal and written skills in English, German is a plus;


Thank you for your application!