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:
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 new 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
6. Packaging Validation & Qualification:
- Execute packaging validation (PV)
- Support equipment qualification (IQ/OQ/PQ)
- Ensure compliance with validation requirements
7. MVTR Evaluation:
- Conduct and interpret MVTR studies
- Evaluate barrier properties of packaging materials
8. Shop Floor Monitoring & Support:
- Monitor packaging operations
- Provide troubleshooting support
9. Equipment Handling:
- Experience in bottle, blister, pouch,sachet and secondary packing machines
- Support machine trials and optimization
10. Regulatory Compliance & cGMP:
- Ensure compliance with USFDA/EU/WHO regulations
- Support audits and maintain inspection readiness
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
From this union, we established two focused, standalone companies:
– Keenova Therapeutics, a branded therapeutics business
– Par Health, a generics and sterile injectables business
To learn more, follow Keenova and Par Health on LinkedIn and visit keenova.com and parhealth.com.
