Packing Head - Injectables Manufacturing

Role Title: Packing Head - Injectable Manufacturing (Including Visual Inspection & Device Assembly Operations)
Reporting To: Site Operations Head

Position Details:

• Position Title: Packing Head Injectables Manufacturing
• Site: FTO 11
• Location: Pydibhimavaram
• Experience: 15+ years

Key Responsibilities / Required Experience:

The candidate should have strong experience in the following areas:

• Injectable packing operations
• Cartoning and labeling machines
• Assembly machines and assembly line operations
• Packaging automation systems
• Track & Trace / Serialization systems
• Visual inspection systems
• Thermal sterilizers
• SAP / MES

Regulatory & Compliance Exposure:

• Strong understanding of cGMP and Data Integrity requirements
• Exposure to regulatory audits such as USFDA, MHRA, EU GMP, WHO GMP, etc.
• Experience in handling deviations, investigations, and CAPA implementation

Role Title: Packing Head - Injectable Manufacturing (Including Visual Inspection & Device Assembly Operations)
Reporting To: Site Operations Head

Purpose of the Role: Lead and manage end-to-end packaging operations for sterile injectable products, including Visual Inspection (Manual & Automated), Device Assembly/Device Packing operations, serialization, labeling, secondary packaging, and dispatch readiness, ensuring compliance with GMP, quality, safety, productivity, and cost objectives.

Key Responsibilities

1. Packaging Operations Management

• Lead end-to-end packing operations for sterile injectable products including vials, cartridges, prefilled syringes, and combination products.
• Ensure planned production volumes are achieved while meeting quality, delivery, and compliance requirements.
• Drive Overall Equipment Effectiveness (OEE), throughput, and packing line productivity.
• Ensure line clearance, batch changeovers, reconciliation, and batch closure activities are performed as per SOPs.

2. Visual Inspection Operations

• Manage manual and automated visual inspection processes for injectable products.
• Ensure defect identification capability and qualification of visual inspectors.
• Monitor inspection trends, defect classification, rejection rates, and inspection efficiency.
• Ensure qualification, validation, and periodic requalification of automated inspection systems.
• Drive continuous improvement to reduce false rejects and improve inspection accuracy.

3. Device Assembly & Combination Product Operations

• Oversee assembly, packaging, and inspection of medical devices and drug-device combination products.
• Ensure compliance with device regulations and applicable quality standards.
• Manage operations involving autoinjectors, safety devices, pens, prefilled syringes, and associated accessories.
• Ensure device traceability, component reconciliation, and assembly controls.

4. Quality & GMP Compliance

• Maintain strong GMP culture across packaging, visual inspection, and device operations.
• Ensure adherence to Data Integrity, ALCOA+, Good Documentation Practices, and Quality Systems.
• Support audits by regulatory agencies and customers.
• Drive closure of deviations, CAPAs, market complaints, and inspection observations.

5. People Leadership

• Lead and develop managers, supervisors, engineers, and shop-floor teams.
• Build multi-skilled workforce across packaging, visual inspection, and device operations.
• Drive training effectiveness, succession planning, and capability building.
• Foster a culture of accountability, engagement, and continuous improvement.

6. Safety, Health & Environment

• Ensure compliance with EHS requirements and safe operation of packaging equipment.
• Drive risk assessments, behavior-based safety, and incident prevention programs.
• Promote safe handling of materials, sharps, and device components.

7. Operational Excellence & Cost Leadership

• Drive Lean, Kaizen, TPM, Jishu Hozen, and digitalization initiatives.
• Reduce packing losses, rejection rates, changeover times, and downtime.
• Lead automation and digital transformation projects within packing operations.

8. Cross-Functional Coordination

• Collaborate with Production, QA, QC, Engineering, Warehouse, Supply Chain, and Regulatory Affairs.
• Ensure timely material availability and production planning execution.
• Support technology transfers, product launches, validations, and commercial readiness activities.