Validation Specialist CSV

  • Salary: Competitive
  • REF Number: 00052156
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 12.11.2021
  • Sector: Pharmaceutical
  • Location: Bern, Bern Area
  • Discipline: Science - QA/Validation

QLS are recruiting for a Validation Specialist CSV to join an important project with a Global Pharmaceutical Company at their site based in Bern on a contract basis until end of 2022 with option of an extension.

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 andreports
  • Support test execution
  • Support and train team members in CSV methodology
  • Supporting the timely and effective completion of investigations, change controls and CAPA’s

Candidate’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 knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21CFR part 11, ...)
  • Good 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 agreedtimelines.
  • Good verbal and written skills in English, German is a plus

F or more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email Please could you send any correspondence inEnglish. Please quote reference QLS 00052156 in all correspondence.

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