Executive/Senior Executive - Formulation Development

Job Description

1. Good Documentation Practices, Compliance for Standard Operating Procedures, Quality Management Systems shall be followed. 2. Review and understanding of product related technicalities for smooth transfer of products to Internal Manufacturing facility of Strides or External Facility. 3. Co-ordination and collection of technical documents from internal sites. 4. Review of Tech pack documents and sharing (MFR, MPR, Spec/STP, BMR, BPR, Tool drawings layouts etc.) to Internal or external manufacturing sites. 5. Review of Master documents before initiating validation batches at Internal or external manufacturing sites. 6. Handling of Investigation related to OOS/OOT/Deviation occurred/reported for New Products and Site Transfer Projects. 7. Conducting/Monitoring of Feasibility trials/ Scale up trials at R&D or Manufacturing site. 8. To be involved in cost improvement program for identified product, to change the formula and improvise the process as required. 9. Handling of Product Robustness Projects and related activities like conducting the trials at R&D, Execution and Monitoring of Optimization batches and Registration/Commercial batches for PR projects. 10. Handling of Trouble shooting to improve the product quality attributes. 11. Review of APQR, RCI, CAPAs, PDR and other related documents. 12. Handling of QMS events (CC/Deviations) in Trackwise. 13. Ensure Test license availability at R&D & Plant. 14. Ensuring Toolings and RMs availability for execution of lab trial batches, PO/PE/Scale up batches and monitoring the batches during execution. 15. Preparation and Review of Trial Reports, and Investigational Summary Reports. 16. Preparation and Review of Documents i.e. MFRs, BMRs, BPRs, Protocols/Reports, QRM for Trial/Feasibility, PO and New Products, various batch sizes and subsequent revisions of all kinds. 17. Review & Approval of PVP & PVR. 18. Preparation and review of stability protocol for experimental batches. 19. Initiation/approval of the test request for the analysis. 20. Process optimization activities for internal/external products as identified and assigned. 21. GMP, GDP, Quality Management systems and SOP shall be followed to ensure the continuous compliance.