Visual Inspection Subject Matter Expert- Parenteral Products

Role Summary

Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. Responsible for overseeing and enhancing the visual inspection program to ensure high quality standards, providing expert guidance on inspection methodologies, leading training, optimizing systems, harmonizing control strategies across manufacturing networks, and ensuring regulatory compliance.

Responsibilities

• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring regulatory compliance and industry best practices.
• Evaluate and validate visual inspection processes, including manual and automated methods, to achieve optimal quality outcomes.
• Establish risk-based inspection strategies for different parenteral products and materials (e.g., vials, syringes).
• Harmonize visual inspection control strategies across internal and external manufacturing networks.
• Serve as the go-to expert on visual inspection processes, equipment, and quality standards for parenteral product lines.
• Conduct root cause analyses and implement CAPAs for quality-related events.
• Collaborate with QA, manufacturing, engineering, and TSMS to implement process improvements that enhance efficiency and reduce inspection errors.
• Develop and deliver training programs for quality inspectors, operators, and relevant staff focusing on visual inspection of parenteral products and GMP adherence.
• Mentor junior staff and develop training materials to promote inspection skills and quality awareness.
• Ensure compliance with FDA and global regulatory standards by keeping inspection processes and documentation up-to-date and audit-ready.
• Participate in internal and external audits, providing expert insights for inspection-related findings.
• Develop and maintain internal quality system documents and execution documents to support the visual inspection Quality System.
• Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.
• Identify opportunities for process automation and work with engineering teams to implement new tools and technologies.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or related field (advanced degree preferred).
• 10+ years of experience with parenterals in a GMP-regulated environment, including 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; leadership experience.

Skills

• Analytical and problem-solving skills with attention to detail.
• Strong collaboration with cross-functional teams.
• Experience with automated inspection systems and AI for quality control is a plus.
• Ability to design and implement training programs and materials.

Education

• Bachelor’s degree required; advanced degree preferred.

Additional Requirements

• Travel 40-50% (domestic and international).
• On-site presence; not a remote position.