Source description
About the role
- Responsible for execution of projects as per the committed timelines. 2. Responsible for API calculation as per the project requirements. 3. Perform feasibility assessment of new projects. 4. Co-ordinate with project management team to ensure adherence to project timelines. 5. Co-ordinate with sourcing department for the timely availability of materials for progress of the development activities. 6. Co-ordinate with licensing department for the availability of licenses for submission batches. 7. Co-ordinate with technology transfer/manufacturing department for smooth transfer of new products from Research and development to commercialization. 8. Responsible for timely availability of documents to support the dossier compilation and regulatory filing and address regulatory queries. 9. Responsible for addressing regulatory deficiencies in co-ordination with cross functional teams. 10. Preparation, approval & implementation of SOPs and relevant training activities & records. 12. Ensure the compliance to the laid down systems and procedures by the team members. 13. Responsible for designing experimental design (DoE) composition and process optimization, statistical analysis, defining design space, statistical data interpretation and report preparation. 14. Responsible for preparation of PDP and PDR. 15. Execution of trouble shooting during routine formulation development. 16. Responsible for assessment and providing justification for the BE failure and increase in impurity during stability studies. 17. Responsible for execution and supervision of lab scale development work of formulation development projects.
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