m / m with formulation development experience
1. To develop oral dosage forms such as tablets and capsules for regulated markets of EU and US.
2. To assist in preparation of equipment qualification protocol & qualify the equipment for routine operations.
3. To assist in procurement of materials, equipment accessories and change parts.
4. To carry out API-excipient compatibility studies; detailed literature search, review the patent summaries / search reports.
5. To carry out formulation development work and operate wide range of formulation equipment.
6. To assist FD executives in performing process optimization studies.
7. To document activities as per Good Documentation Practices.
8. To prepare SOPs, Process Validation Protocols and Reports
9. To assist in carrying out process validation studies of selected formulations.
10. To assist and perform technology transfer of formulations, any where in the country or Europe.
11. To manufacture commercial batches of approved formulations
12. Review Equipment Cleaning Validation data and reports.
13. To review equipment calibration data & logs, cleaning logs, equipment usage logs.
14. To review equipment calibration / validation status, prepare new logbooks and co-ordinate with QA for issue of new logbooks.
15. To carry out stability studies of in-process as well as finished dosage forms as per ICH guidelines.
16. Depending on company’s requirements, above responsibilities can change and additional responsibilities may be included.