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Job Description

1. Experience in Formulation R&D product development with experience in injectable product development in Novel drug delivery systems/Lyophilized product/Solution product. 2. To do literature search relevant to projects requirement and understanding of Regulatory guidance.
3. To procure raw materials (API/excipients), packaging materials and Reference product in consultation with packaging/purchase department.
4. To prepare request application for Testing/analysis license for new product/Reference product.
5. To design, conduct pre-formulation and formulation developmental experiments with QbD approach and to enter the details about drug product manufacturing experiments in Lab Notebook.
6. To prepare TR/IOM for the respective API/Excipients/product sample analysis.
7. To prepare product development/stability study protocols and reports, prepare SOPs for related laboratory equipment/instrument and maintain critical data records for regulatory audits.
8. To prepare document for Technology Transfer like sheet II, Master Formula, Risk assessment based upon CPP & CQA, FMEA and SDS.
9. Group work for lab management, handling instrument, common group activities and co-ordination with cross functional teams for handling projects issue.
10. To support cross functional activities at plant for Scale- up/ Exhibit batches/commercial batches and new assignments.
11. Preparation of Product development report (PDR), Risk assessment reports and do compilation of project issues.
12. To comply with the internal quality system while performing any activity.