- To ensure availability of the technical package & documents related to Technology Transfer as per GMP & regulatory requirements.
- To prepare document for site transfer project as per regulatory and customer requirements.
- Preparation of Documents like Batch Manufacturing Record, Quantitative Formula Record, and Master Formula Card, Equipment equivalency report for recent Site Transfer Product, Exhibit Batch and New Launch Products.
- To prepare sampling protocol, process validation protocols, stability study protocols, hold time study protocols and miscellaneous study protocols as per Regulatory market requirement.
- Handling of Track wise, SAP and LMS.
- Preparation of SOP & Guidelines for Equipment's/Instruments/Formulation development (OSD) etc.
- To review LNB, executed batch BMR, Process validation protocols, feasibility report & Miscellaneous study report.




- Coordinate with intra and inter department within and outside the plant for timely completion of activity related to Technology Transfer.
- To review Knowledge sharing Presentation of site shift products, which includes Product history, Critical Process Parameters, Critical Quality Attributes, Trend data of Analytical Results, equipment equivalency evaluation, market complaint details and Stability results trend analysis data.
- Preparation of licensing applications including but not limited to API, RLD justification, CPD.
- Maintaining departmental tracking activity for API, RM, PPM, RLD receipt and issuance.
- Compilation of technical data for both API and Finished product. i.e. specifications, development reports data, validation reports data.

📌 Documentation Executive (Baska)
🏢 BDR GROUP
📍 Baska