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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Quality (QA-QC) |
EmploymentType | Full-time |
- Responsible for compilation and review of dossier for a product for the regulated markets and customers - Circulate checklist for dossier requirements - Coordinate with R&D, QA, QC and production for documents - Prepare Module 1 and Module 2 (Quality) and Module 3 as in eCTD/ NeeS as per EU / ANDA requirements or country specific requirements - Hyperlink and upload the dossier in eCTD software - Circulate query checklist and compile query response - Compile documents for post approval variations - Compilation of annual reports and renewal documents,
Keyskills :
annual reportsandaneessoftwarecompilationAnnual MeetingsPrint CollateralAnnual ReviewsAnnual PlanningQuarterly ReportingLetterheadBookletsPostcardsAnnual BudgetsGxPChange ControlQuality Auditing