09 Oct
|
DR REDDYS
|
Visakhapatnam
09 Oct
DR REDDYS
Visakhapatnam
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:
- Robust 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 & Setting
- 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.
📌 Packing Head - Injectables Manufacturing (Visakhapatnam)
🏢 DR REDDYS
📍 Visakhapatnam