Stability Enrollment, Trending, and Documentation Scientist-2
Tasks
- Apply risk based approach for regulatory compliance
- Assemble analyze and report stability data
- Author stability initiation documents
- Author stability sections of CTD dossiers
- Create LIMS studies and manage data
- Create and track stability annual requirements
- Ensure training requirements are met
- Enter stability data and generate stability reports
- Follow stability procedures and ensure compliance
- Initiate commercial stability studies
- Maintain stability performance expertise
- Manage batch identification
- Manage projects and escalate issues to meet milestones
- Own stability deviations
- Support change controls and CAPA
- Support health authority inspections
- Track stability batch enrollment
- Trend stability data using statistical packages
Perks/Benefits
- N/A
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 | Regulatory Affairs | SAP | Stability Studies | Statistical Analysis | TrackWise | Veeva
Education
Roles
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