Officer- RA & Tech Transfer

V S International; Munger; Presencial; INR 600.000 - 1.200.000; Jornada completa

Descripción de la vacante

V S International is seeking a qualified professional to lead technology transfer activities for new products from R&D to manufacturing and between sites in India. You will coordinate cross-functional teams including R&D, Production, QA/QC, Engineering, and Regulatory Affairs to ensure smooth product transfers.

Responsibilities include preparing and reviewing Technology Transfer Protocols, Reports, and risk assessments, monitoring trial, exhibit, and validation batches, and ensuring adherence to

Formación

• Coordinating tech transfer activities from R&D to manufacturing and across sites.
• Prepare and review tech transfer protocols, reports, and risk assessments.
• Coordinate cross-functional teams (R&D, Production, QA/QC, Engineering, Regulatory).
• Monitor trial, exhibit, and validation batches during technology transfer.
• Ensure cGMP, ICH guidelines, ALCOA+ and Data Integrity throughout transfers and regulatory work.

Responsabilidades

• Monitor trial batches, exhibit batches, process optimization and validation batches during technology transfer.
• Prepare regulatory documentation and support product registrations, renewals and variations.
• Support internal, customer, and regulatory inspections with compliance records.

Conocimientos

Technology transfer

Regulatory documentation

cGMP compliance

ICH guidelines

Data integrity

Educación

B.Pharma / M.Pharma

Descripción del empleo

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 [e-mail].