CSV Engineer (m/f)

REFERENZNUMMER:

323914/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist