Officer- RA & Tech Transfer

Role & responsibilities

-Coordinating technology transfer activities for new products from R&D to manufacturing and from manufacturing sites to receiving sites.

- Prepare and reviewed Technology Transfer Protocols, Reports, and risk assessment in accordance with approved procedure.

-Coordinating cross-functional teams including R&D, Production, QA, QC. Engineering, and Regulatory Affairs for successful product transfer.

-Monitor trial batches, exhibit batches, process optimization, and validation batches during technology transfer.

- Ensure compliance with cGMP, ICH guidelines, ALCOA+ principles, and Data Integrity requirements throughout technology transfer activities.

-Prepare, review, and compiled regulatory for product registrations, renewals and post-approval variations in accordance with country-specific regulatory requirements.

- Support internal, customer, and regulatory inspections by providing regulatory documentation and compliance records.

Preferred candidate profile

B.Pharma/M.Pharma candidates with relevant experience in the OSD formulation industry may share their profiles at [email removed].