Validation Specialist Audit Trail

  • Salary: Competitive
  • REF Number: 00052148
  • 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 to join an important project with a Global Pharmaceutical Company at their site based in Bern on a contract basis until end of September 2022 with option of an extension.

Main responsibilities:

  • Support closing a CPA regarding audit trail review for QC equipment
  • Categorize all QC GxP systems according to global SOP and define the frequency of System Audit Trail review based on risk.
  • Perform a System Audit Trail review for those systemsthat require it based on their categorization.
  • Set up a maintenance task in SAP to plan subsequent reviews

Candidate’s Requirements:

  • Degree in a Life Sciences/ Biotechnology, Chemistry discipline or comparable work experience
  • Severalyears 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, 21 CFR 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 agreed timelines.
  • Good verbal and written skills in English, German is a plus

For 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 in English. Please quote reference QLS 00052148 in all correspondence.

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