Assistant Manager - Packaging & Development (Daman)

Authorization & Review

• Review and sign the following documents:
• Exhibit Batch Packing Record
• Exhibit Batch Protocol
• Exhibit Batch Report
• Scale-up/Packaging Trial Batch Protocol and Report
• Master Packaging Record for site transfer projects
• PM BOM (Bill of Materials)
  

Documentation & Compliance

• Prepare and review Exhibit Batch BPRs.
• Ensure adherence to:
• cGMP (Current Good Manufacturing Practices)
• GDP (Good Documentation Practices)
• Regulatory compliance
• QMS (Quality Management System) activities within the PDL department
  

Operational Oversight

• Monitor execution of Scale-up, Feasibility, and Exhibit batches in the packaging area.
• Prevent mix-ups and cross-contamination.
• Identify and manage incidents, deviations, and change controls related to packaging.
• Ensure readiness and execution of MVTR (Moisture Vapor Transmission Rate) studies.
  

Cross-functional Coordination

• Coordinate with SCM, F&D, and P&D (Central) teams for seamless product transfer from lab scale to plant.
• Collaborate with relevant departments to prepare packaging plans for scale-up, exhibit, and validation batches.
  

Technical Evaluation & Execution

• Evaluate change parts required for Scale-up, Feasibility, and Exhibit batches.
• Prepare machine equivalency comparisons.
• Execute packaging trials, prepare trial reports, and maintain lab notebooks.
  

Problem Solving & Continuous Improvement

• Troubleshoot packaging-related issues.
• Conduct investigations and root cause analysis.
• Perform any other duties assigned by superiors.