QC Qualification and Validation Specialist
QC Qualification and Validation Specialist
Jobdescription
Your Profile:
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
Luca Furler
Über die Firma
