Sr Research Associate, Technical Services

Overview

Senior Research Associate, Technical Services responsible for coordinating technology transfer activities, documentation, investigations, and regulatory/compliance support to ensure smooth site execution and approvals.

What you'll do

• Coordinate submission, site transfer, validation, and lifecycle management for technology transfer.
• Evaluate and finalize documents and processes for successful execution and implementation at site.
• Align team members and CFTs through discussions to meet project timelines.
• Support preparation, review, approval, and monitoring of engineering, submission, and validation batch documents.
• Prepare placebo batches and submit them to QC for testing per project requirements.
• Handle investigations to improve quality documentation and define next steps.
• Support regulatory filings and handle CMC queries for on-time product approvals and launch readiness.

What you'll need

• Experience handling technology transfer execution, documentation, filing support, and related activities (exact years not stated).
• Ability to perform risk evaluation and gap analysis for projects.
• Ability to finalize batch sizes and manage prerequisites procurement before site commencement.
• Qualified auditor capability for internal audits.
• Knowledge/awareness of EHS policy and significant environmental aspects and impacts.
• Ability to ensure cGMP at the site level.

Details

• Location: Pudupakkam, India.