Lead Executive - Stability Data Analytics
Mumbai, MH, IN, 40079
INR 1200K-1783K (estimate) Senior-level Full Time
Tasks
- Conduct trend analysis
- Coordinate stability data analytics department training
- Ensure summary reports are correct and complete
- Evaluate stability data to ensure justified shelf life
- Interpret statistical analysis from NWA software
- Notify QA product review group of adverse trends
- Perform shelf life extensions and reductions
- Perform stability data trending for investigations
- Perform stability impact assessments for out of trend results
- Prepare annual stability review contribution packages for APQR
- Prepare annual stability summary review packages
- Prepare stability summary reports within compliance timelines
- Prepare summary reports for special projects and product evaluations
- Provide stability data for customer product compliance files
- Review stability data from third party affiliates
- Summarize and review stability data
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Data | Analytical data interpretation | CGMP | Data Analysis | Data Interpretation | EU regulations | FDA Regulations | Good Manufacturing Practice | Good documentation | Good documentation practice | LIMS | Microsoft Office | NWA | Pharmaceutical Quality | Pharmaceutical quality control | Quality Control | Regulatory Compliance | SAP | Stability Testing | Statistical Analysis | TrackWise | Trend analysis
Education
Roles
Analyst | Data Analyst | Lead | Lead Stability Data Analyst | Stability Data Analyst
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