Technology transfer - R&D (Walk-in Drive)

Role & responsibilities

1. Initiation of New Product Introduction (NPI) procedure for new product manufacturing at manufacturing site.

2. To prepare action plan and manage the scale up/Tech transfer activity of formulations from lab scale to pilot/commercial scale.

3. Trouble shooting of problems arising during manufacturing.

4. To prepare and review Exhibit batches Batch manufacturing record (BMR) and Batch packaging record (BPR).

5. To execute trial/Scale up/Optimization/Exhibit batches and preparation of summary reports.

6. To support regulatory filing by providing intended commercial batch manufacturing record (BMR), Batch packaging record (BPR) and stability evaluation summary.

7. To review and provide Critical Process Parameters (CPPs) and Critical Quality Attributes (CQA) as part of Annual Product Review.

8. To identify and manage the project need by co-ordination with cross-functional departments likes supply, marketing, RA, Production, QA, QC etc.

9. To prepare and review specifications, PDR, MFC, BMR, PVP, Scale up reports and QbD documents.

10. To perform Gap analysis and evaluation of manufacturing feasibility for site variation projects.

11. Provide technical inputs for regulatory deficiencies in order to support RA to respond to queries efficiently.