R&D Section Head/ Formulation
Pharma international company
مجموع سنوات الخبرة :7 years, 2 أشهر
1. Follow the R&D policies, procedures and systems to ensure consistent & systematic application of best practices providing timely and effective support to concerned users.
2. Coordinate and monitors the R&D operations and ensures that the projects are executed planned.
3. Coordination of the administrative functions within the R&D such as plans, meeting, extra works, overtimes, appraisal of the employees.
4. Provide monthly & annual reports related to R&D projects activities.
5. Trainings the R&D staff in instrumental SOP's, and System SOP's.
6. Distributes work plan for R&D employee.
7. Supervise &follow the documentation activities within the R&D, and control documents handling.
8. Supervise for the preparation of laboratory batches, pilot batches of new formulated dosage forms for stability purposes & the production of the first three production batches for new products, &Performed troubleshooting.
9. Preparation of products CTD file.
10. Order raw materials, tools, and equipments necessary for development.
11. Help the team whenever there is an over load in work.
12. Ensure implementation of GMP, GDP& GLP requirements within the R&D.
13. Prepared& reviewed stability protocols, specifications, stability study summary.
14. Reviewed the Manufacturing Batch Record & Packaging Batch Record.
15. Prepared & reviewed QC In-Process Specification &R&D Documents (Raw materials & Finished Products) Specifications, Master Formula, Batch Formula, Manufacturing Procedures, Production Manufacturing Batch Record (Technical Files ))and Process Validation Protocol.
16. Good experience in reply to Deficiency Letters.
17. Studying the In-Vitro dissolution profiles of the development products.
18. Supervise the analyzing formulation development and stability study products.
19. Supported regulatory department by providing stability study summary and other documents required.