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 aguimard@ckqls.ch. Please could you send any correspondence inEnglish. Please quote reference QLS 00052156 in all correspondence.

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