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 aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS 00052148 in all correspondence.

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