Visual Inspection Subject Matter Expert- Parenteral Products

Role Summary

Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. Oversees and enhances visual inspection programs to ensure high quality standards, provides guidance on inspection methodologies, leads training, optimizes systems, harmonizes control strategies across manufacturing networks, and drives regulatory compliance.

Responsibilities

• Visual Inspection Program Development: Lead design, development, and implementation of visual inspection standards for parenteral products; evaluate and validate manual and automated inspection methods; establish risk-based inspection strategies; harmonize control strategies across internal and external networks.
• Technical Expertise & Process Optimization: Serve as the go-to expert on visual inspection processes, equipment, and quality standards; conduct root cause analyses and implement CAPAs; collaborate with QA, manufacturing, engineering, and TSMS to improve processes and reduce inspection errors.
• Training & Development: Develop and deliver training for quality inspectors, operators, and relevant staff; mentor junior staff and create training materials to promote inspection skills and quality awareness.
• Compliance & Documentation: Ensure compliance with FDA and global regulatory standards; keep inspection processes and documentation audit-ready; participate in audits and support inspection-related findings; develop and maintain internal quality system documents and execution documents for the visual inspection Quality System.
• Innovation & Continuous Improvement: Explore new technologies and methodologies (including AI) to improve accuracy and efficiency; identify opportunities for automation and work with engineering to implement new tools.

Qualifications

• Bachelor‚Äôs degree in Pharmacy, Chemistry, Engineering, or a related field (advanced degree preferred).
• 10+ years of experience with parenterals in a GMP-regulated environment, with at least 5+ years in visual inspection for injectable products.
• In-depth knowledge of visual inspection standards, practices, and equipment for parenteral products.
• Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections.
• Preferred: proven track record of developing training programs and mentoring inspection teams; strong analytical and problem-solving skills; experience with automated inspection systems and/or AI for quality control; formal or technical leadership experience.

Skills

• Visual inspection methodologies and equipment
• Quality systems, CAPA, and regulatory compliance
• Cross-functional collaboration (QA, manufacturing, engineering, TSMS)
• Training development and mentoring
• Process optimization and automation awareness

Education

• Bachelor‚Äôs degree in Pharmacy, Chemistry, Engineering, or related field (advanced degree preferred)

Additional Requirements

• Travel: This role requires travel (40-50%) domestically and internationally.
• On-site presence required; this is not a remote position.