Sr. Executive /Assistant Manager Packaging Development Pharma Co. Pune

Job description

Key Responsibilities

1. Packaging Development

• Develop primary, secondary, and tertiary packaging for new product launches.
• Develop and approve change parts for blister, bottle, carton, strip, sachet, and other packaging formats.

2. Packaging Material Development

• Develop and qualify new packaging materials in coordination with vendors.
• Select suitable packaging materials based on product and regulatory requirements.

3. BOM & Documentation

• Prepare and review PM-BOM, packing profiles, packaging specifications, drawings, and standards.
• Maintain packaging documents, change controls, and revision history.

4. Artwork Management

• Coordinate artwork development and approvals for cartons, labels, leaflets, foils, and shippers.
• Ensure compliance with regulatory, marketing, and customer requirements.

5. Packaging Validation

• Conduct packaging trials, machine trials, stability studies, and validation activities.
• Prepare trial reports and validation documentation.

6. Regulatory Compliance

• Ensure compliance with GMP, WHO, USFDA, EU GMP, MHRA, TGA, CDSCO, and Schedule M guidelines.
• Support regulatory submissions and labeling compliance.

7. Vendor Development

• Identify, qualify, and audit packaging material vendors.
• Coordinate supplier development and CAPA implementation.

8. Cost Optimization

• Identify cost-saving opportunities through material optimization and alternate sourcing.
• Standardize packaging components and reduce packaging waste.

9. Complaint Investigation

• Investigate packaging-related complaints using RCA.
• Implement CAPA in coordination with QA and Production.

10. Cross-Functional Coordination

• Work closely with R&D, Production, QA, QC, Regulatory Affairs, Purchase, Supply Chain, Marketing, Engineering, and external vendors.

11. Documentation & Compliance

• Maintain packaging specifications, SOPs, validation reports, development records, and artwork approval documents.

12. Continuous Improvement

• Improve packaging quality, efficiency, machine productivity, and sustainability.
• Support serialization and digital packaging initiatives.

Required Skills:

• Pharmaceutical Packaging Development
• Packaging Material Selection
• Packaging Machine Knowledge
• Artwork Development & Management
• Packaging Validation & Line Trials
• Vendor Development & Qualification
• Packaging Cost Optimization
• Technical Documentation
• Project Management
• MS Office