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QC Qualification and Validation Specialist.

job details

summary.

  • specialism
    engineering
  • contact
    Luca Furler
  • reference number
    20301

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job details

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 equipment’s 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 CAPA’s


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

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 equipment’s 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 CAPA’s


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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LF

Luca Furler

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