Executive

Year Tandalja, Vadodara, Gujarat, India

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Position : Executive/Sr. Executive\xe2\x80\x93 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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