Validation Specialist (QC equipment)

Posted 08 November 2021
Job type Limited
DisciplineLife SciencesQuality Assurance/Safety

Job description

For our client a Global Pharmaceutical Company in Bern, we are currently looking for a new team member as

Validation Specialist (QC equipment)

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 systems that require it based on their categorization.
  • Set up a maintenance task in SAP to plan subsequent reviews

Who we are looking for

  • 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, 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

Workplace: Bern
Workload: 100%
Working Time: flexible working hours
Start Date: 01.12.2021
Duration: 09 months

Your Application
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).