Assembly & Packaging Lead / Manager

Responsibilities • Lead startup, commissioning, qualification, validation, and operational readiness for Assembly, Visual Inspection, and Packaging operations. • Provide technical and operational leadership to ensure safe, compliant, and efficient manufacturing execution. • Oversee equipment lifecycle management, including qualification, validation, maintenance, troubleshooting, and continuous improvement. • Drive visual inspection programs, defect management, POD studies, QRA assessments, and process optimization. • Lead engineering runs, media fills, process validation, PPQ, and commercial manufacturing activities. • Collaborate with cross-functional teams to support NPI, technology transfer, process improvements and product lifecycle management. • Ensure compliance with cGMP, FDA, EMA, PIC/S, ICH, Annex 1, and customer requirements while maintaining inspection readiness. • Lead investigations, deviations, CAPAs, risk assessments, and Change Controls to ensure product quality and compliance. • Drive operational excellence through performance monitoring, productivity improvements, quality enhancement, and cost optimization. • Review and approve GMP documentation, including SOPs, batch records, protocols, reports, and training materials. • Oversee QMS activities, audits, inspections, data integrity, and regulatory commitments. • Manage department resources, project timelines, and production priorities to meet business objectives. • Serve as a key contact for customers, auditors, and regulatory authorities. • Coach and develop teams while promoting a culture of safety, quality, compliance, and continuous improvement. • Provide leadership during critical manufacturing operations, validation campaigns, and regulatory inspections. • Accountable for overall operational, technical, quality, compliance, and business performance. Requirements • Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or related field • 5+ years of experience in drug product manufacturing • Extensive experience in pharmaceutical manufacturing, particularly visual inspection and packaging operations. • Strong knowledge of cGMP and global regulatory requirements, • Strong technical, analytical, troubleshooting, root cause investigation, and decision-making skills.