Title: Senior Executive

Date: Jun 24, 2025

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd

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.