Officer- RA & Tech Transfer

V S International; Munger; On-site; INR 600,000 - 1,200,000; Full time

Job summary

V S International is seeking a Technology Transfer Specialist to coordinate product transfers from R&D to manufacturing and between sites. You will ensure cGMP compliance and prepare protocols, risk assessments, and regulatory records.

Role requires coordinating with R&D, Production, QA/QC, Engineering, and Regulatory Affairs to ensure successful transfers and support inspections. Email resumes to [e-mail].

Qualifications

• B.Pharm/M.Pharm with relevant experience in OSD formulation industry.

Responsibilities

• Coordinate technology transfer activities for new products from R&D to manufacturing and between sites.
• Prepare and review Technology Transfer Protocols, Reports, and risk assessments according to approved procedures.
• Coordinate 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 during technology transfer.
• Prepare, review, and compile regulatory documents for product registrations, renewals and variations per country regulations.
• Support internal, customer, and regulatory inspections by providing regulatory documentation and compliance records.

Education

B.Pharma / M.Pharma

Job description

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].