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 the highest quality standards, providing expert guidance on inspection methodologies, leading training programs, optimizing systems, harmonizing control strategies across the manufacturing network, and driving 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 cross-functional teams to identify and implement process improvements that reduce inspection errors.
• Develop and deliver training programs for quality inspectors, operators, and other staff, focusing on visual inspection 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, keeping inspection processes and documentation audit-ready.
• Participate in audits, providing expert insights and support 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 work 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 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: Experience with automated inspection systems and/or AI for quality control; formal or technical leadership experience.

Skills

• Strong analytical and problem-solving abilities with attention to detail.
• Excellent collaboration and cross-functional communication skills.
• Ability to design and deliver effective training programs.
• Proficiency with quality systems, CAPA management, and audit readiness.
• Familiarity with automated inspection technologies and AI applications in quality control.

Education

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

Additional Requirements

• This role requires travel (40-50%) both domestic and international.
• This is an on-site position (not remote).