PRINCIPAL SCIENTIST
- India
- Permanent
- Full-time
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 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 QualificationsRequired Education Qualification: M.Pharma
Required Experience: 6 - 9 years