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Qualification / Validation Expert (Department QC Microbiology) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Support
Projektbeschreibung
REFERENZNUMMER:
347213/11
IHRE AUFGABEN:
-Qualification/validation tasks for a new isolator for sterility testing
-Hands-on engineering tasks in the isolator qualification/validation
-Counterpart to external engineering project leader
-Coordination and attendance of relevant project meetings (represents user-group)
-Qualification of different smaller technical projects e.g. monitoring systems, filter integrity test device, glove testing devices
-Coordination and attendance of relevant project meetings
-Hands-on qualification/validation tasks
-Author of technical SOPs and Author of URS
-Technical risk assessments, change management tasks, support of maintenance tasks
-Trouble shouting regarding technical challenges in Sterilab
IHRE QUALIFIKATIONEN:
-Master in Engineering or higher automation education
-Relevant industrial experience, ideally background on sterility laboratory isolator technology before
-Experience in regulative compliance
-Advanced GMP documentation skills are a must
-Intermediate German and English levels are required
WEITERE QUALIFIKATIONEN:
Quality manager, Qualification/validation specialist
347213/11
IHRE AUFGABEN:
-Qualification/validation tasks for a new isolator for sterility testing
-Hands-on engineering tasks in the isolator qualification/validation
-Counterpart to external engineering project leader
-Coordination and attendance of relevant project meetings (represents user-group)
-Qualification of different smaller technical projects e.g. monitoring systems, filter integrity test device, glove testing devices
-Coordination and attendance of relevant project meetings
-Hands-on qualification/validation tasks
-Author of technical SOPs and Author of URS
-Technical risk assessments, change management tasks, support of maintenance tasks
-Trouble shouting regarding technical challenges in Sterilab
IHRE QUALIFIKATIONEN:
-Master in Engineering or higher automation education
-Relevant industrial experience, ideally background on sterility laboratory isolator technology before
-Experience in regulative compliance
-Advanced GMP documentation skills are a must
-Intermediate German and English levels are required
WEITERE QUALIFIKATIONEN:
Quality manager, Qualification/validation specialist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges