Senior Executive

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• To design and conduct experiments for preformulation, formulation optimization of Injectable and long acting complex non oral dosage form (Implant, In-situ-gel, etc.) based on QbD approach.
• To execute the experiments as per Design of experiments
• To do literature search, patent search and prepare summary report for ANDA projects.
• To prepare product development study protocols and reports as per regulatory requirements.
• To enter the experimental details, observations and test request in the eLNB/METIS software.
• Experimental trials and stability study results compilation and interpretation using MINITAB software.
• To have sound knowledge in Lyophilization cycle development & terminal sterilization.
• To prepare Technology Transfer documents like MF, Risk Assessment based upon CPP & CQA,
• To prepare justification for import material, documents for form 29 application and Common Pharmaceutical Document for DCGI submission.
• To execute scale up / exhibit batches at plant and prepare scale up summary report
• To prepare Stability protocol as per regulatory requirement.
• To prepare Product Development Report, Risk assessment report for Elemental impurities, Residual solvents and Extractable for regulatory submission.
• To prepare pre-ANDA meeting package, scientific justification and /or report for various regulatory agency
• To prepare SOPs related to laboratory equipment / instrument.
• To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
• To comply with the internal quality system while performing any activity.
• To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity.
  

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