Srabani Samanta

Technology Transfer Department - Micro Labs Pvt. Ltd. - Bangalore, India

(2023-12 - 2025-08)

Preparation and review of BOM, Feasibility Protocol, Master formula record, Batch Manufacturing Records, Batch Packaging Record.
Review of Dossiers, Transferring documents, Process Validation Protocol and Report, Hold time study, RM and FP Specification.
Initiation of QMS related documentation for new product commercialization &Technology Transfer of site.
Collection of data from transferring site and Preparation of Gap assessment.
Coordination, Planning of Feasibility batches wherever required.
Planning, Coordination and follow-up with R&D & other transferring sites related to technology transfer projects.
Responsible for smooth transfer of technology and Monitoring of validation Batches.
Coordination with Stakeholder's i.e. RA, QA, QC, Production, Engineering, Warehouse to ensure successful Technology transfer.
A Good understanding of thawing process, Sterilization Process, Vial washing, X-ray & Visual inspection process.
A thorough understanding of sterilization process, sterile injectable technology like Aseptic filled products, terminally sterile products.
Good understanding of CAPA management, Change control management.
Exposure of QRM, as per ICH Q9 skill & investigation tools & root cause Identification tools.

MS&T (R&D) - Strides Pharma Science Ltd. - Bangalore, India

(2025-09)

Preparation of Batch manufacturing Protocol (BMP), Trial manufacturing Protocol (TMP), Master formula record (MFR), Process optimization Protocol (POP), Process Optimization Waiver Report (POWR) or Process Optimization Report (POR), Quality Risk Management (QRM), Drug Master File checklist, Stability Protocol, Feasibility trial Report.
Purchase Request for Raw material, Packing material, create the Item code, SFG code, FG code, Change order through Product lifecycle management (PLM).

About