Executive - Formulation Orals

4 days ago

Tandalja Vadodara Gujarat, India Sun Pharmaceutical Industries Ltd Full time

**Position **:Executive/Sr. Executive
- Formulation Development (Orals)

**Exp** : 2 to 5 years

**Education** : M.Pharm

**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

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