Executive - Formulation R&d
5 months ago
**Job Summary**
- As a Product Robustness Review and Compliance Team member, work profile would be product robustness assessment, review of technical documents, harmonization related activities, compliance related activities
- 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 and PAR rule Assessment
- To drive the PRRC stage gates and maintain action tracker
- Responsible to perform and review statistical assessment using statistical tools such as JMP, Minitab
- Responsible for S1/S2 probability assessment, shelf life extrapolation, inverse extrapolation, DOE etc
- Prepare/ review of formulation optimization & process optimization design and report. Support the formulation team in design of optimization plan
- Prepare, revise and review internal/ harmonised SOPs and guideline.
- Provide review comments on GQS/GSOPs, prepare gap assessment.
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