

CMC Specialist 100% (m/f/d)
- Change assessments for multisite biologic products including clarification with SMEs
- Assessing changes and supporting submission with CMOs
- Revision of technical documentation
- Managing operational activities for the variation submissions e.g uploads of documents, maintaining trackers, QC of submission packages
- Compliance check of 32A1 part of the dossiers
- Maintaining information in submission tracking systems
- Knowledge about Establishment and process for Change Control
- Knowledge about international Guidelines for Post-Approval CMC Changes
- CMC Dossier structure for biologics
- Authoring and managing review process of biological dossiers
- Experience in Qualification, Cleaning and Validation will be beneficial
- Profound experience in Trackwise
- Teamplayer Mentality
- English fluently is mandatory
- A very renowned company
- Pleasant working atmosphere
Reference number
578623/1
Contact
Phone:
+41 44 225 50 00
E-Mail:
positionen@hays.ch
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