Sun Pharma is the fourth largest generic pharmaceutical company in the world It is also India's largest and most valuable pharmaceutical enterprise by size and market capitalization. The company provides high quality medicines trusted by customers and patients in over ISO countries and has multiple manufacturing facilities and R&D centers. Our leadership is approachable, recognizes people's passions for growth, gives them a voice and empowers them to make a positive change.
Post : Executive - Formulation R&D
Job Description
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
• To update the development checklist and review for its application in drug product development
• 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.
Additional Information
Experience : 2+ years
Location : Tandalja - R&D
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Formulation R&D
End Date : 20th September 2023
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