Role & responsibilities

1. Responsible for smooth and hassle free transfer of technology from Donor site to receiver site.

2. Overall monitoring of all production and analytical activities carried out for technology transfer.

3. Receive the technology transfer documents from Donor site and review the same.

4. Responsible for initiation of material procurement, consumptions, analytical and manufacturing

documentation.

5. Responsible for review of Technology Package Documents.

6. Responsible for co-ordination for feasibility trials, scale up batches and exhibit batches.

7. Responsible for preparation and revision of TTD SOPs and training to staff members.

8. To review stability data and compilation of product data for regulatory submissions in coordination

with Donor site.

9. Responsible for review of protocols and process validation documents involved in transfer of

technology.

10. To mitigate the challenges observed in transfer of analytical method and manufacturing process

by taking trials.

11. Responsible to undertake key studies associated with the product, formulation manufacturing

process and technical trouble shooting for smooth commercial manufacturing.

12.



Responsible for review of analytical test procedures and test reports.

13. Responsible to discuss with Production team on process equipment and criticalities to ensure

smooth plant operations.

14. Responsible for Improvisation of the process with respective to safety, cost, environment,

engineering, and feasibility for scale up by applying fundamentals of engineering.

15. Responsible to manage the modification and equipments’ for start of recent product

manufacturing.

16. Support in identification and generation of facilities required in production and Quality Control

Department for smooth execution of drug product.

17. Responsible for regulatory query response for process development work.

18. Support to QA on technical for OOS, OOT and carry out changes to prevent failures in futures.

19. To follow cGMP, GLP, GDP and other pharmaceutical guidelines to comply the regulatory

guidelines.

20. Co-ordination with various cross-functional teams for smooth execution of drug product.

Preferred candidate profile

Transdermal and Solid Orals

📌 Assistant/Deputy Manager - Technology Transfer (Bengaluru)
🏢 SHILPA MEDICARE
📍 Bengaluru