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

• 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