QC Qualification and Validation Specialist

vor 2 Wochen


Bern, Schweiz Randstad Vollzeit

For our client, a pharmaceutical company based in Bern, we are seeking a Quality Control Qualification and Validation Specialist.

General Information:
 

  • Start date: ASAP
  • End date: 31.12.2024
  • Extension: possible
  • Workplace: Bern
  • Workload: 100%



    Main Responsibilities: 
     

    • Archival of QC Analytical equipmentâs electronic data according to Pharma regulations, site procedures and IT policies
    • Definition of the validation strategy and compliance activities required for archival of electronic data
    • Coordination of computerized system qualification and validation activities within the Quality Control department
    • Perform and/or support the writing of specification documents (URS)
    • Review test protocols, plans and reports
    • Support test execution
    • Support and train team members in CSV methodology
    • Supporting the timely and effective completion of investigations, change controls and CAPAâs

      Your Profile:
       
      • 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, ...)
      • Strong understanding of the process of electronic data archival within a GMP environment
      • Good understanding of analytical technologies
      • Good IT knowledge
      • 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


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