Description
We are looking for a
CSV Engineer (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in the Bern region
Branch: Forschung und Entwicklung im Bereich Biotechnologie
Your tasks:
- Planning, coordination and execution of all phases for computerised system validation
- Review and evaluation of validation results
- Preparation of GMP-compliance documentation for computerised system validation
- Performance of risk/criticality assessments
- Presentation, as subject matter expert, of the domain of responsibility during inspections and audits
- Ensure compliance with 21 CFR Part 11 requirements and predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures and documentation
- Writing and reviewing system validation and testing plans, validation and test summaries and reports, user acceptance test plans, traceability matrices, test defect reports and IQ/OQ/PQ protocols and test scripts
- Implement validation assessments and gap analyses ensuring compliance with 21 CFR Part 11 requirements and predicate GxP standards
Your qualifications
- Master´s/Bachelor´s degree in natural sciences or degree in applied sciences or equivalent
- Profound know-how of computerised system validation
- Experience in inspection of regulatory agencies
- Analytical thinking and problem-solving ability
- Open, dynamic and communicative personality
- Motivated team player, flexible and driven to produce work of high quality
- Capable of planning, organising and executing own work
- Fluency in German or/and English
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung und Qualifizierung