Urgent Requirement For Technology Transfer

Role & Responsibilities:

1. Preparation of project plan and timeline as per the scope of the project and also based on the various activities and in agreement with client.

2. Procurements of API / RM /PM / Consumables and it follow up with purchase and QC for receipt, sampling, testing and approvals.

3. Ensure all the Gland project team is available for all project meetings as per the agreed meeting schedule.

4. Responding to the client queries in timely manner in coordination with other internal departments or team members.

5. Ensure that, all the required documents are reviewed and controlled by relevant cross functional teams and are made available as per the project timeline.

6. Conducting the pre-SB batches meeting with internal team to ensure there is effective technology transfer (no deviations and quality issues).

7. Follow up with internal department and also with client (if applicable) to close deviations, change controls, incidents of the project (if any).

8. Responsible in involve/monitor of trial, submission and process validation batches that are manufactured for dossier submission.

9. Ensure that manufactured SB batches are optically inspected and packed for stability initiation within the stipulated timeline.

10. Ensure that, all the required documents for dossier compilation are provided to Gland DRA in timely manner (as per the agreed timeline) so that, the Gland DRA can review and provide the documents to client DRA for dossier filing and update the stability data to client.