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Quality Management Assurance Pharma
Eingestellt von FERCHAU GmbH aus Gummersbach
Gesuchte Skills: Support
Projektbeschreibung
* Risk Assessment for BOPPs
* Preparation of risk assessments
* Overview of submitted reports and planning of necessary testing activities
* Evaluation, compliance check and gap analysis of a registration dossiers from external partners intended for in-licensing (Due Diligence)
* Support to answer deficiency letters from Health Authorities
* Evaluation and reviewing of upcoming changes related to initial launches or initial proactive global harmonization of compliance status
VORAUSSETZUNGEN:
* Operational / hands on CMC Writing experience for Pharma products (generics a plus)
* Technical dossier expertise (eg. analytical / qualification) either leading or reviewing / participating in compliance gap analysis and closure
* Experience in regulatory registration processes for initial submission and maintenance activities (incl. in EU DCP/MRP, Latin America)
* Strong English-skills
Projektdetails
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Einsatzort:
Darmstadt, Deutschland
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Projektbeginn:
asap
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Projektdauer:
32 Woche(n)
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges
FERCHAU GmbH
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Straße:
Steinmüllerallee 2
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Ort:
51643 Gummersbach, Deutschland