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QC Qualification and Validation Specialist
vor 1 Monat
For our client, a pharmaceutical company based in Bern, we are seeking a Quality Control Qualification and Validation Specialist.
General Information:
Archival of QC Analytical equipment's electronic data according to Pharma regulations, site procedures and IT policiesDefinition of the validation strategy and compliance activities required for archival of electronic dataCoordination of computerized system qualification and validation activities within the Quality Control departmentPerform and/or support the writing of specification documents (URS)Review test protocols, plans and reportsSupport test executionSupport and train team members in CSV methodologySupporting the timely and effective completion of investigations, change controls and CAPA's
Your Profile:
Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experienceSeveral 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 environmentGood understanding of analytical technologiesGood IT knowledgeStrong analytical thinking and problem-solving abilityExcellent communication and teamwork skillsAbility to simultaneously support multiple projects, duties and assignments and prioritize accordinglyExcellent 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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