Summary:
Responsible for end-to-end manufacturing and packing operations of ophthalmic and respiratory products, ensuring quality, compliance, productivity, planning, budget adherence, and people development.

KRA:
Manufacturing Operations, Production Planning, Regulatory Compliance, Quality Management, Resource Optimization, Team Development, Audit Readiness and Budget Management

Key Responsibilities:
• Ensure products are manufactured and stored in accordance with approved documentation to achieve required quality standards.
• Approve production instructions and ensure their strict implementation.
• Review, evaluate and authorize production records through designated personnel.
• Manage end-to-end manufacturing and packing operations of ophthalmic and respiratory products, including terminal sterilization.
• Prepare and execute weekly and monthly production plans in coordination with Supply Chain.
• Coordinate with QA, QC, Regulatory, Supply Chain and SRC teams to ensure adherence to production plans and timely batch release.
• Monitor line efficiency, productivity,



product yield and wastages, and implement corrective actions as required.
• Investigate and address production deviations impacting quality, yield or timelines.
• Ensure accurate and timely online documentation of BMRs, BPRs and related records in compliance with SOPs and regulatory requirements (USFDA, MHRA, TGA, MCC, WHO).
• Ensure batch transactions and production data are updated in ERP systems on a real-time basis.
• Review Batch Manufacturing Records (BMR), Batch Filling Records (BFR) and Batch Packing Records (BPR).
• Review and approve SOPs, validation protocols and qualification documents.
• Ensure compliance with cGMP guidelines and regulatory requirements; document and investigate all deviations.
• Ensure qualification, validation and maintenance of production facilities, equipment and utilities.
• Coordinate with Validation, Engineering and QA for media fill studies, equipment qualificatio

📌 Head of Manufacturing (Nalagarh)
🏢 Sentiss Pharma
📍 Nalagarh