Stability Enrollment, Trending, and Documentation Scientist-1
Tasks
- Assemble analyze and report stability data
- Author stability initiation documents
- Author stability sections for CTD dossiers
- Create and manage LIMS studies
- Create and track stability annual requirements
- Enter and report stability data
- Follow stability procedures and ensure consistency
- Identify batches per annual program
- Initiate commercial stability studies
- Maintain stability performance expertise
- Manage project milestones and issues escalation
- Meet training requirements
- Own stability related deviations
- Support change controls and CAPA
- Support health authority inspections
- Track stability batch enrollment
- Trend stability data using statistical software
- Use risk based approach for compliance
Perks/Benefits
Skills/Tech-stack
21 CFR | CAPA | CGMP | CTD | Change Control | Data trending | ICH Q1A | ICH Q5C | JMP | LIMS | Management System | Microsoft Office | Quality Management System | Quality management | SAP | Stability Testing | Statistical Analysis | TrackWise | Veeva
Education
Roles
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