Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India's No. 1 company in Pharmaceutical sector.
Post : Executive / Sr. Executive – Formulation Development (Orals)
Job Summary
• As a Product Robustness Review and Compliance Team member, work profile would be product robustness assessment, review of technical documents for all markets, harmonization related activities, compliance related activities
• Document management
• Should have knowledge of formulation development, statistics, statistical tools and knowledge of regulatory guidelines/requirements
Area of Responsibility
• Review of technical documents for adequacy, raw data and quality of documents within defined SLA for regulated markets.
• Product Robustness Assessment.
• To perform and review statistical assessment using statistical tools such as JMP, Minitab for S1/S2 probability assessment, shelf life extrapolation, inverse extrapolation, DOE etc.
• Prepare, revise and review internal/ harmonised SOPs and guideline.
• Document Management- Provide document numbering and keep a record of the same as per SOP/guideline, issuance, archival and retrieval of documents & LNBs, inventory management for LNBs. Share historical data available in database with the team whenever required.
• Manage and provide inputs in Laserfische scanning of documents for EDAMS archival.
• Train the trainer activities.
• QMS related activities in track wise.
• EDMS related support
Additional Information
Experience : 2 to 5 years
Qualification : M.Pharm
Location : Tandalja - R&D
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Formulation Orals
End Date : 20th June 2024
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