Research Associate
- Assist the execution of commercial launches and process validation batches at manufacturing sites (in-house and CMO).
- Execute scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.
- Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports.
- Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.
- Participate in process investigations, troubleshooting, and deviation handling during trial and commercial validation batches.
- Assist in equipment selection and capacity assessment based on product-specific requirements.
- Ensure document readiness for regulatory submissions, respond to technical queries, and support audit preparation.
- Support internal and external/vendor audits by providing required documentation and technical inputs.
- Prepare data summaries, technical reports, and presentations as per project or management requirements.
- Maintain accurate records, follow applicable SOPs, and ensure strict GMP compliance in all operations.