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Role & responsibilities

Job Description

Plan and coordinate all pre-scale-up activities for new and existing products.
Review product development data and manufacturing requirements prior to scale-up execution.
Ensure readiness of manufacturing facilities, equipment, materials, and documentation for scale-up activities.
Lead scale-up activities for products at loan license facilities and company manufacturing locations. Prepare, review, and submit comprehensive scale-up reports.
Co-ordinate with cross-functional teams including Production, QA, QC, R&D, Regulatory Affairs, and Supply Chain for smooth product launches.
Check and review technical documents including Master Formula Record (MFR), Technology Transfer Protocol (TTP), Technology Transfer Report (TTR), Batch Manufacturing Records (BMR), and related technical documents.
Conduct, observe, and evaluate demo batches, exhibit batches, validation batches, and commercial batches across all dosage forms.
Conduct technical and facility audits at new manufacturing sites as per management/CMD requirements. Support departmental objectives and continuous improvement initiatives.

Preferred candidate profile

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