Manager 2

1. To design and conduct experiments for preformulation, for non oral dosage form on QbD approach. 2. To execute the experiments as per Design of experiments 3. To do literature search, prepare summary report and review for ANDA projects. 4. To prepare product development study protocols and reports as per regulatory requirements. 5. To enter the experimental details, observations and test request in the eLNB/METIS software. 6. Experimental trials and stability study results compilation and interpretation using MINITAB software. 7. To prepare Technology Transfer documents like MF, Risk Assessment based upon CPP CQA, 8. To prepare justification for import material, documents for form 29 application and Common Pharmaceutical Document for DCGI submission. 9. To execute scale up / exhibit batches at plant and prepare scale up summary report 10. To prepare Stability protocol as per regulatory requirement. 11. To prepare Product Development Report, Risk assessment report for Elemental impurities, Residual solvents and Extractable for regulatory submission. 12. To prepare pre-ANDA meeting package, scientific justification and /or report for various regulatory agency 13. To prepare SOPs related to laboratory equipment / instrument. 14. To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents. 15. To comply with the internal quality system while performing any activity. 16. To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity.