SCIENTIST

Department Details

Role Summary

MSAT - OSD (Oral Solids)

Key Responsibilities

MSAT (Manufacturing Site And Technology Transfer)
1. Monitoring of Pilot Bio batches, Scale up batches, Exhibit batches, Query response batches and Validation batches.
2. Preparation of GAP analysis, MFC, BSP and Sampling plan for exhibit batches and intended commercial batches.
3. Review of documents for Pilot Bio batches, Scale up batches, Exhibit batches and Validation batches.
4. Facility evaluation before batch execution at manufacturing facility.
5. To do tech-transfer (Technology transfer) and execution to CMO site, complying quality and regulatory requirement
6. Preparation of department SOP's and its implementation.
7. Co-ordination with the various customer department like Regulatory affairs, Quality assurance, Quality control, Project management, stability, R & D and production to fulfill their relevant requirement for the timely delivery of products.
8 To ensure the adherence to all the EHS policies.
9 To provide support Pre-filing and post-filing support to regulatory team.
10 Facilitation of quality management implementation.

Educational Qualifications

Required Education Qualification:
Required Experience: 1 - 6 years