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 qualification and facility qualification as per approved schedules.
- Participate in market complaint investigations and product recall activities.
- Ensure readiness for and successful handling of internal, customer and regulatory audits.
- Maintain adequate inventory of manufacturing consumables and coordinate material planning to address shortages or excess stock.
- Prepare and monitor departmental budgets for manpower and consumables.
- Ensure initial and ongoing training of department personnel and conduct Training Need Identification (TNI) for team members.
- Drive continuous improvement in operational efficiency, compliance, quality and cost management.

Must Have’s:

- Strong experience in sterile ophthalmic manufacturing.
- Proven exposure to USFDA/EU regulated facilities.
- Experience in production planning, regulatory compliance and audit management.
- Robust leadership and people management capability.

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