To provide the value addition (technically) throughout the development process and to achieve successful on time filing. 2. To have strong execution skills and to interact cross functionally and ensure timely submission and approval of the assigned projects as per agreed work plan. 3. To navigate the project technically and provide feasible technical solutions so as to develop a product recipe that can be successfully manufacture post approval. 4. To conduct Literature search and Patent search for assigned project. 5. To perform pre-formulation and formulation development trials with QbD approach and therefore to develop a robust formulation. 6. To manufacture batches for stability studies. 7. To manufacture batches for analytical method development and validation. 8. To troubleshoot commercial products and newer products to be scaled up. 9. To ensure successful scale up/exhibit batches at plant. 10. To prepare and review Test Request for analysis of raw material (API/excipients) and Drug product. 11. To write Laboratory Notebook to enter the details about drug product manufacturing operation. 12. To prepare Development Study Protocol and execute the development study accordingly. 13. To prepare Development Study Report after receipt of COAs. 14. To prepare Stability protocol and charge stability batches as per the protocol. 15. To prepare stability compilation sheet based on available COAs. 16. To fill form 29 for the grant of manufacturing license for the purpose of Examination, Testing and Analysis. 17. To prepare Technology Transfer documents like Sheet II, MPS, MF, Risk Assessment based upon CPP & CQA, FMEA and MSDS. 18. To prepare Common Pharmaceutical Document for DCGI submission. 19. To prepare Pre-IND/IND/NDA Package, Product Development Report based on studies performed and available COA for Regulatory submission. 20. To prepare Product Development Report along with relevant back-up data. 21. To prepare in process and finished product Specification. 22. To prepare SOPs related to laboratory equipment / instrument. 23. To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents. 24. To comply with the internal quality system while performing any activity. 25. To timely respond FDA query, if any. STANDARD OPERATING PROCEDURE TITLE: Organogram and Job Description preparation Document No. Version No. & Status Effective Date Review Due Date SOP023892 3.0 & Effective 10-Jan-2023 09-Jan-2026 Page 2 of 2 26. To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity. "The above job responsibilities are not limited and the person shall fulfill additional responsibilities given by group leader / department head, if any." Responsibilities assigned and approved by: (Group Leader / Section Head - Reporting Authority) Name, Sign and Date Responsibilities accepted by: I have read and understood the responsibilities mentioned above. Employee Name, Sign and Dat
