Senior Executive Formulation Development Orals

3 weeks ago


Vadodara, Gujarat, India SUN PHARMA Full time

Job Summary:

At SUN PHARMA, we are seeking a highly skilled Senior Executive Formulation Development Orals to join our team. As a key member of our Product Robustness Review and Compliance Team, you will be responsible for product robustness assessment, review of technical documents for all markets, harmonization related activities, and compliance related activities.

Key Responsibilities:

  • Review of technical documents for adequacy, raw data, and quality of documents within defined SLA for regulated markets.
  • Product Robustness Assessment.
  • 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 guidelines.
  • Document Management - Provide document numbering, keep a record of the same as per SOP/guideline, issuance, archival, and retrieval of documents and LNBs, inventory management for LNBs.
  • 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.

Requirements:

  • M.Pharm degree.
  • 2 to 5 years of experience in formulation development.
  • Knowledge of formulation development, statistics, statistical tools, and regulatory guidelines/requirements.


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