Head of Manufacturing

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.
• Strong leadership and people management capability.