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Validation Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
325410/1
IHRE AUFGABEN:
-Participate in the implementation of validated computerized systems
-Take over validation activities for laboratory systems (GC, LC, and other analytical equipment)
-Develop validation plans based on available templates
-Develop user and functional requirements documentation, based on available templates, existing documentation for other systems, and information from SMEs
-Review vendor IQ-OQ documentation in collaboration with SMEs
-Develop performance qualification protocols and traceability matrices, based on templates, existing documentation for other systems, information from SMEs, and vendor IQ-OQ documentation
-Organize and follow execution of performance qualification tests
-Perform review of executed operational and performance qualification tests
-Develop validation report for laboratory systems, based on templates and generated validation documentation
-Manage relations with QA concerning validation activities (meetings with QA to discuss validation documentation, corrections stemming from QA review of the validation documentation)
-Manage change control documentation for validated systems and/or validated excel spreadsheets, including related testing
-Prepare validation documentation for archiving
-Perform reviews of validation status of validated systems (Performance Monitoring)
IHRE QUALIFIKATIONEN:
-Bachelor's or Master's degree
-Knowledge in Quality Assurance, and especially in performing QA related tests
-Experience in validation of laboratory systems
-GxP experience
-Fluency in English
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
325410/1
IHRE AUFGABEN:
-Participate in the implementation of validated computerized systems
-Take over validation activities for laboratory systems (GC, LC, and other analytical equipment)
-Develop validation plans based on available templates
-Develop user and functional requirements documentation, based on available templates, existing documentation for other systems, and information from SMEs
-Review vendor IQ-OQ documentation in collaboration with SMEs
-Develop performance qualification protocols and traceability matrices, based on templates, existing documentation for other systems, information from SMEs, and vendor IQ-OQ documentation
-Organize and follow execution of performance qualification tests
-Perform review of executed operational and performance qualification tests
-Develop validation report for laboratory systems, based on templates and generated validation documentation
-Manage relations with QA concerning validation activities (meetings with QA to discuss validation documentation, corrections stemming from QA review of the validation documentation)
-Manage change control documentation for validated systems and/or validated excel spreadsheets, including related testing
-Prepare validation documentation for archiving
-Perform reviews of validation status of validated systems (Performance Monitoring)
IHRE QUALIFIKATIONEN:
-Bachelor's or Master's degree
-Knowledge in Quality Assurance, and especially in performing QA related tests
-Experience in validation of laboratory systems
-GxP experience
-Fluency in English
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges