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 and processes to ensure high quality standards, providing expert guidance on inspection methodologies, leading training, optimizing systems, harmonizing visual inspection control strategies across the manufacturing network, 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 and practices across the internal and external manufacturing network.
• Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines.
• Conduct root cause analyses and implement CAPAs for quality-related events.
• Collaborate with QA, manufacturing, engineering, and TSMS to identify and implement process improvements to enhance efficiency and reduce inspection errors.
• Develop and deliver training programs for quality inspectors, operators, and other staff, focusing on visual inspection and GMP requirements.
• 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 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 in visual inspection, including AI, to enhance accuracy and efficiency.
• Identify opportunities for process automation and collaborate with engineering to implement new tools.

Qualifications

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

Skills

• Visual inspection methodologies
• CAPA and root cause analysis
• Cross-functional collaboration
• Training program development
• Quality systems documentation
• Process optimization and automation
• Regulatory compliance (FDA/EMA/ICH)

Education

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

Additional Requirements

• Travel: 40-50% domestic and international.
• On-site role; not remote.