Visual Inspection Program Leader
Core
Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.
Role type
Senior Program Leader, Visual Inspection (Pharmaceuticals)
Builds
Visual inspection control strategies and defect management systems for parenteral products
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Visual inspection standards design, automated and manual inspection evaluation, risk-based inspection strategy, defect catalogue management, root cause analysis, CAPA implementation, GMP compliance, audit support, training program development, process automation, AI technology evaluation
Preferred skills
Cross-functional collaboration, mentorship, continuous improvement methodologies
Technologies
AI, automated inspection equipment
Responsibilities
Lead design and implementation of visual inspection standards for parenteral products; Evaluate and validate manual and automated inspection processes; Establish risk-based inspection strategies for vials and syringes; Manage Defect kit implementation and Defect catalogue; Conduct root cause analyses and implement CAPAs; Develop and deliver training programs for inspectors and operators; Ensure compliance with FDA and global regulatory standards; Explore and evaluate new technologies including AI for inspection enhancement
Seniority
Senior, hands-on IC with program leadership
