1. Key Result Areas (KRAs)

1.1 Production Planning & Manpower Management

- Plan and execute packing activities in accordance with the approved production schedule to achieve monthly and annual business targets.
- Ensure optimum utilization of manpower, machines, and packing materials to maximize productivity and efficiency.
- Allocate officers, supervisors, operators, and workmen to packing lines based on production requirements, competency, training, and qualification.
- Monitor manpower deployment and ensure compliance with statutory requirements, company policies, and applicable labour agreements.
- Ensure adequate training, skill development, and competency assessment of all packing personnel.

1.2 Packing Operations Management

- Oversee all primary and secondary packing operations to ensure compliance with approved Batch Packing Records (BPR), Standard Operating Procedures (SOPs), cGMP, Data Integrity, and regulatory requirements.
- Ensure proper line clearance, machine setup, process verification, reconciliation, and documentation before, during, and after packing operations.
- Review and approve Batch Packing Records, equipment logbooks, reconciliation reports, and related production documents before submission to Quality Assurance.
- Ensure effective implementation of serialization and Track & Trace systems, including DGFT and PharmaSecure software for export products.

1.3 Quality & Regulatory Compliance

- Ensure full compliance with cGMP, Good Documentation Practices (GDP), Data Integrity requirements, and applicable regulatory guidelines.
- Coordinate with Quality Assurance, Quality Control, Engineering, Warehouse, and Supply Chain departments for smooth execution of packing activities.
- Lead investigations related to deviations, non-conformances, market complaints, out-of-specification observations, and implement effective Corrective and Preventive Actions (CAPA).
- Ensure timely closure of Change Controls, Deviations, CAPA, audit observations,



and regulatory commitments.
- Support internal, customer, and regulatory audits, including USFDA, MHRA, WHO-GMP, and other inspections.

1.4 Productivity & Continuous Improvement

- Monitor daily production output, Overall Equipment Effectiveness (OEE), machine utilization, line efficiency, and packing productivity.
- Ensure achievement of production targets while maintaining product quality, safety, and regulatory compliance.
- Analyze production losses, rejection trends, downtime, and implement corrective actions to improve operational efficiency.
- Drive Lean Manufacturing, 5S, Kaizen, and continuous improvement initiatives within the packing department.
- Monitor packing material consumption and ensure effective reconciliation to minimize wastage.

1.5 Equipment & Maintenance Coordination

- Coordinate preventive maintenance, calibration, and qualification activities for packing equipment to ensure maximum equipment availability.
- Coordinate with the Engineering Department for timely breakdown maintenance and implementation of equipment improvements.
- Ensure proper operation and maintenance of serialization equipment, labelling machines, checkweighers, cartonators, collators, wrapping machines, and inspection systems.

1.6 Cost Control & Resource Management

- Monitor departmental operating expenses and optimize resource utilization without compromising quality or compliance.
- Control packing material losses and ensure effective inventory management.
- Identify cost-saving opportunities through process improvements and waste reduction initiatives.





1.7 Team Leadership & Employee Development

- Lead, motivate, and develop departmental personnel to build a high-performance team.
- Conduct performance reviews, identify training needs, and develop succession plans for key positions.
- Promote a culture of discipline, teamwork, employee engagement, safety, and continuous learning.

1.8 Safety, Setting & EHS Compliance

- Ensure compliance with Environment, Health & Safety (EHS) requirements and company safety policies.
- Promote safe working practices and investigate incidents, near misses, and unsafe conditions.
- Ensure housekeeping, cleanliness, and workplace organization in accordance with cGMP and 5S standards.

2. Other Responsibilities

2.1 Planning & Coordination

- Prepare daily, weekly, and monthly packing plans in coordination with Production Planning, Warehouse, and Supply Chain departments.
- Review production performance and implement action plans to achieve departmental objectives.

2.2 Quality Management System (QMS)

- Ensure effective implementation of the Quality Management System by managing Change Controls, Deviations, CAPA, Risk Assessments, Audit Compliance, Product Quality Reviews, and Market Complaint investigations.

2.3 Audit & Regulatory Readiness

- Maintain the department in a constant state of audit readiness and ensure compliance with all applicable regulatory and customer requirements.

2.4 Management Reporting

- Prepare and present departmental MIS reports covering productivity, manpower utilization, OEE, rejection trends, deviations, training status, and key performance indicators (KPIs).

2.5 Additional Responsibilities

- Perform any other responsibilities assigned by the Plant Head or Senior Management in line with organizational objectives.
- Ensure continuity of departmental operations by delegating responsibilities during the absence of key personnel.

📌 Manager / Sr. Manager - Ophthalmic Packing (Maharashtra)
🏢 FDC
📍 Maharashtra