Visual Inspection Subject Matter Expert- Parenteral Products

Role Summary

Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will oversee and enhance the visual inspection program and processes to ensure high quality standards, provide expert guidance on inspection methodologies, lead training programs, optimize systems, harmonize control strategies across manufacturing networks, and drive regulatory compliance. Strong technical knowledge, analytical skills, and a commitment to product quality and patient safety are required.

Responsibilities

• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.
• Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes.
• Establish risk-based inspection strategies for different types of 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 corrective and preventive actions (CAPAs) for quality related events.
• Collaborate with cross-functional teams (QA, manufacturing, engineering, TSMS) to identify and implement process improvements that enhance efficiency and reduce inspection errors.
• Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements.
• Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization.
• 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 and support for any inspection-related findings.
• Act as subject matter expert for the development and maintenance of 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, working closely with engineering teams to implement new tools and technologies.

Qualifications

• Required: Bachelor‚Äôs degree in Pharmacy, Chemistry, Engineering, or a related field (relevant advanced degree preferred).
• Required: 10+ years of experience with parenterals in a GMP-regulated environment, with at least 5+ years of experience in visual inspection for injectable pharmaceutical products.
• Required: In-depth knowledge of visual inspection standards, practices, and equipment specific to 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 a commitment to quality.
• Preferred: Experience with automated inspection systems and/or artificial intelligence for quality control.
• Preferred: Formal or technical leadership experience.

Skills

• Visual inspection methodologies and technologies (manual and automated)
• CAPA and root cause analysis
• Quality systems and regulatory compliance (FDA, EMA, ICH)
• Cross-functional collaboration (QA, manufacturing, engineering, TSMS)
• Training program design and delivery
• Process optimization and automation
• Innovation in inspection technologies and AI applications

Education

• Bachelor‚Äôs degree in Pharmacy, Chemistry, Engineering, or a related field; advanced degree preferred

Additional Requirements

• This role will require travel (40-50%) both domestic and international.
• On-site presence required; not a remote position.