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Qualification and Validation Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design, Support
Projektbeschreibung
REFERENZNUMMER:
298310/11
IHRE AUFGABEN:
-Define the qualification strategy for production/laboratory equipment, facilities, utilities and computerised Systems (CSV)
-Perform the qualification of new or upgraded production/laboratory equipment, facilities, utilities and CSV through the preparation of the necessary documentation and tests execution
-Contribute as SME to the URS preparation in support to the user for all defined steps
-Perform the impact assessments, design, prepare the commissioning and qualification documents and qualification reports
-Maintain the qualification status of existing systems production/laboratory equipment, facilities, and utilities according to a predefined frequency and in accordance with current internal SOPs
-Ensure compliance with the qualification standards of the equipment/utilities through continuous updating of procedures, according to international GMP standards and internal procedures
IHRE QUALIFIKATIONEN:
-Superior understanding of CSV (profound relevant experience)
-Advanced knowledge in working with 21 CFR 820 and 21 CFR 820.100
-Experience in the pharma/medical or consumer product industry
-Fluency in English and German
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
298310/11
IHRE AUFGABEN:
-Define the qualification strategy for production/laboratory equipment, facilities, utilities and computerised Systems (CSV)
-Perform the qualification of new or upgraded production/laboratory equipment, facilities, utilities and CSV through the preparation of the necessary documentation and tests execution
-Contribute as SME to the URS preparation in support to the user for all defined steps
-Perform the impact assessments, design, prepare the commissioning and qualification documents and qualification reports
-Maintain the qualification status of existing systems production/laboratory equipment, facilities, and utilities according to a predefined frequency and in accordance with current internal SOPs
-Ensure compliance with the qualification standards of the equipment/utilities through continuous updating of procedures, according to international GMP standards and internal procedures
IHRE QUALIFIKATIONEN:
-Superior understanding of CSV (profound relevant experience)
-Advanced knowledge in working with 21 CFR 820 and 21 CFR 820.100
-Experience in the pharma/medical or consumer product industry
-Fluency in English and German
WEITERE QUALIFIKATIONEN:
Qualification/validation specialist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges