- Assist the execution of commercial launches and process validation batches at manufacturing sites (in-house and CMO).
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Execute scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.
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Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports.
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Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.
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Participate in process investigations, troubleshooting, and deviation handling during trial and commercial validation batches.
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Assist in equipment selection and capacity assessment based on product-specific requirements.
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Ensure document readiness for regulatory submissions, respond to technical queries, and support audit preparation.
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Support internal and external/vendor audits by providing required documentation and technical inputs.
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Prepare data summaries, technical reports, and presentations as per project or management requirements.
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Maintain accurate records, follow applicable SOPs, and ensure strict GMP compliance in all operations.
M. Pharma with 2-5 years of experience in execution of process validation batches
