Summary To manage and execute packaging development, validation, and shop floor operations in compliance with regulatory requirements, ensuring robustness, efficiency, and compliance of packaging systems across regulated markets.
Key Responsibilities
- Artwork Evaluation & Approval:
- Review and evaluate packaging artworks for compliance with regulatory and marketing requirements
- Coordinate with QA, Regulatory Affairs, and vendors for artwork approval
- Ensure correct implementation of printed packaging materials
- Packaging Development & Change Management:
- Design and develop primary, secondary, and tertiary packaging configurations
- Manage packaging change parts design, modification, and implementation
- Execute feasibility studies and provide technical inputs for current product introduction
- Ensure compatibility of packaging with product and machinery
- Material Approval System (MAS):
- Initiate and manage material approval processes
- Evaluate vendor samples and ensure compliance to specifications
- Support vendor qualification and packaging material standardization
- Packaging Specifications & Documentation:
- Develop and review packaging specifications
- Prepare Master Packaging Records (MPR), SOPs, protocols, and reports
- Ensure documentation aligns with cGMP and regulatory requirements
- Shipping Studies & Stability Support:
- Design and execute shipping validation studies
- Support packaging design for transportation robustness
- Packaging Validation & Qualification:
- Execute packaging validation (PV)
- Support equipment qualification (IQ/OQ/PQ)
- Ensure compliance with validation requirements
- MVTR Evaluation:
- Conduct and interpret MVTR studies
- Evaluate barrier properties of packaging materials
- Shop Floor Monitoring & Support:
- Monitor packaging operations
- Provide troubleshooting support
- Equipment Handling:
- Experience in bottle, blister, pouch,sachet and secondary packing machines
- Support machine trials and optimization
- Regulatory Compliance & cGMP:
- Ensure compliance with USFDA/EU/WHO regulations
- Support audits and maintain inspection readiness
📌 Deputy Manager, Technical Services (Chennai/Indore) (India)
🏢 Endo
📍 India