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.
Job Description
Key Responsibilities:
1. 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
2. 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
3. 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
4. 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
5. Shipping Studies & Stability Support:
- Design and execute shipping validation studies
- Support packaging design for transportation robustness