Stability Enrollment, Trending, and Documentation Scientist-1
Tasks
- Apply risk based approach for compliance
- Assemble analyze and report stability data
- Author stability initiation documents
- Author stability sections of CTD dossiers
- Create and track stability annual requirements
- Ensure training requirements are met
- Enter stability data and generate reports
- Facilitate initiation of commercial stability studies
- Follow stability procedures and ensure consistency
- Identify batches per annual program
- Lead teams to meet milestones
- Maintain expertise on global stability performance
- Manage LIMS study creation and data
- Manage projects and escalate issues
- Own departmental deviations for stability enrollment operations
- Support change controls and CAPA
- Support health authority inspections
- Track stability batch enrollment
- Trend stability data using statistical analysis
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | CGMP | 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
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
Roles
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