Vadodara
42 minutes ago
30 Applied
JOB ID:163781
Job Type
Returnee Program
Functional Area
Research/Analytics/Business Intelligence/Big data
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
4 - 7 Yrs
Key Skills Required
mf, development study report, risk assessment and fmea
Other Skills Required
Job Description
· Education : M. Pharm
· Experience : 4-7 years
1. To conduct Literature search and Patent search for assigned project.
2. To procure raw materials (API / excipients), packaging materials and innovator samples in consultation with packaging/purchase department.
3. To prepare application for form 29 and form 11 for the grant of manufacturing license for the purpose of Examination, Testing and Analysis and import of RLD.
4. To perform pre - formulation and formulation development trials with QbD approach and therefore to develop a robust formulation.
5. To manufacture batches for stability studies and write experiments in Laboratory Notebook.
6. To prepare Technology Transfer documents like MF, Development Study Report, Risk Assessment and FMEA.
7. To review analytical reports and prepare compilation sheet and discuss results with superior.
8. To co-ordinate with cross functional departments like ADD, RA, QA, Plant for project / product related activity.
9. To prepare SOP's related to systems and la
... See More· Education : M. Pharm
· Experience : 4-7 years
1. To conduct Literature search and Patent search for assigned project.
2. To procure raw materials (API / excipients), packaging materials and innovator samples in consultation with packaging/purchase department.
3. To prepare application for form 29 and form 11 for the grant of manufacturing license for the purpose of Examination, Testing and Analysis and import of RLD.
4. To perform pre - formulation and formulation development trials with QbD approach and therefore to develop a robust formulation.
5. To manufacture batches for stability studies and write experiments in Laboratory Notebook.
6. To prepare Technology Transfer documents like MF, Development Study Report, Risk Assessment and FMEA.
7. To review analytical reports and prepare compilation sheet and discuss results with superior.
8. To co-ordinate with cross functional departments like ADD, RA, QA, Plant for project / product related activity.
9. To prepare SOP's related to systems and laboratory equipment's
10. To be familiar of regulatory guidelines.
11. To execute scale up/ exhibit batches in support with superior.
12. Comply with the systems and SOP’s while execution of experiments.
13. To prepare stability protocol and load the stability batches
14. Review the stability batches data and report preparation.
15. Preparation of specification proposal with justifications
16. Address the regulatory queries. See Less
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
