Sentiss Pharma - Head - 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.

Candidate holding Pharma experience should apply for the role.

Pharma experience is mandatory.

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.

Location and Salary:

Location - Nalagarh, Himachal Pradesh, salary - hidden