Job Description 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.
Job Description
Key Responsibilities:
1. Artwork Evaluation & Approval:
Review and evaluate packaging artworks for compliance with regulatory and marketing requirementsCoordinate with QA, Regulatory Affairs, and vendors for artwork approvalEnsure correct implementation of printed packaging materials2. Packaging Development & Change Management:
Design and develop primary, secondary, and tertiary packaging configurationsManage packaging change parts design, modification, and implementationExecute feasibility studies and provide technical inputs for new product introductionEnsure compatibility of packaging with product and machinery3. Material Approval System (MAS):
Initiate and manage material approval processesEvaluate vendor samples and ensure compliance to specificationsSupport vendor qualification and packaging material standardization4. Packaging Specifications & Documentation:
Develop and review packaging specificationsPrepare Master Packaging Records (MPR), SOPs, protocols, and reportsEnsure documentation aligns with cGMP and regulatory requirements5. Shipping Studies & Stability Support:
Design and execute shipping validation studiesSupport packaging design for transportation robustness6. Packaging Validation & Qualification:
Execute packaging validation (PV)Support equipment qualification (IQ/OQ/PQ)Ensure compliance with validation requirements7. MVTR Evaluation:
Conduct and interpret MVTR studiesEvaluate barrier properties of packaging materials8. Shop Floor Monitoring & Support:
Monitor packaging operationsProvide troubleshooting support9. Equipment Handling:
Experience in bottle, blister, pouch,sachet and secondary packing machinesSupport machine trials and optimization10. Regulatory Compliance & cGMP:
Ensure compliance with USFDA/EU/WHO regulationsSupport audits and maintain inspection readiness