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Quality Control Submission Manager Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- GCP Knowledge
- Regulatory Submission Document Knowledge
WHAT YOU'LL BE DOING:
- Calculating and reporting of monthly key quality metrics in graphical form (ie audit results and corrective and preventive actions status and associated reports)
- Involved in the reconciliation of IND submissions and IND amendments according to an established process
- Follow-up on outstanding corrective and preventive actions, manage to closure
- Coordination and assessment of SOP deviations and their reporting
- Support escalation process of potential issues
- Support for Oncology QA managers with meeting preparation, follow-up etc.
- Support in GCP consultation with business partners
- Support for the preparation of training materials (webinars, slides) and participation in quality training sessions for the business partners
WHAT YOU NEED TO BRING TO THE TABLE:
- Experience in working in Quality in the GCP/clinical development area
- Project management skills and ability to manage others
- Robust understanding of a submission document especially the Clinical Modules (1, 2 and 5); SCE - Summary of Clinical Efficacy, SCS - Summary of Clinical Safety and the Clinical overview
- Robust understanding of GCP requirements and compliance with regulatory requirements
- Robust understanding of key Quality Systems principles (Compliance to SOPs, deviations, corrective and preventive actions, Key Quality Indicators)
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Kara Lloyd
Yoh, a DayJ2W: CLINICAL
MONJOBJ2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
East Hanover, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges