Executive - Formulation Orals
6 months ago
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/requirementsArea 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-
Executive - Formulation Orals
6 months 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...
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Senior Executive Formulation Development Orals
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Executive - Formulation
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Vadodara, Gujarat, India SUN PHARMA Full timeJob Title: Executive Formulation Orals DevelopmentJob Summary:Lead the product robustness assessment and review of technical documents for regulated markets.Conduct statistical assessments using tools like JMP and Minitab for probability calculations, shelf life extrapolation, and inverse extrapolation.Prepare and review internal SOPs and guidelines,...
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Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full timeLiterature search, product understanding, data interpretation for product to be undertaken for development. - Initiation of documents required for product development/movement like T-License, Import License for drug substance as well as reference product and bioequivalence study request. - Design of primary product strategy, preparation of product strategy...
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