Job
Description
Key Responsibilities: Packaging Development Innovation Lead the design, development, and validation of packaging components for existing and new pharmaceutical products. Drive packaging material selection, compatibility studies, and stability protocols in alignment with regulatory requirements (USFDA, EU, WHO, etc.). Implement sustainable, cost-effective, and innovative packaging solutions aligned with global trends. Project Team Leadership Manage a cross-functional team of packaging engineers and associates across development and commercial sites. Provide technical guidance and mentorship to the packaging team. Ensure timely execution of packaging projects, tech transfers, and commercialization activities. Regulatory Compliance Ensure packaging systems comply with cGMP, GDP, regulatory filings (ANDA, NDA, EU Dossier), and serialization norms (USDSCSA, EU-FMD). Support audits (regulatory and customer) by providing necessary documentation and technical justifications. Vendor Material Management Lead vendor development, qualification, and performance evaluation of packaging material suppliers. Collaborate with procurement and quality teams for material approval and cost optimization. Process Excellence Oversee packaging line trials, validation (PQ), and troubleshooting during manufacturing. Drive continuous improvement initiatives using Six Sigma, lean principles, and OEE enhancement. Technology Systems Evaluate and implement modern packaging technologies (Track Trace, tamper-evident packaging, QR coding). Work closely with serialization, automation, and IT teams to ensure integrated packaging solutions
