Inspection Subject Matter Expert

Overview

Sanofi is seeking a dedicated Inspection Subject Matter Expert (SME) based in Waterford, Ireland, to act as the lead technical authority overseeing all visual inspection processes, both Automated Vision Inspection (AVI) and Manual Visual Inspection (MVI). This permanent, full-time role supports the Product Supply APU, ensuring inspection methodologies comply with global standards and regulatory requirements for injectable products.

Key Responsibilities

• Lead and manage the full lifecycle qualification of AVI systems covering User Requirements Specification through Performance Qualification.
• Maintain tuning parameters and challenge protocols to optimize visual inspection equipment.
• Manage requalification, logbooks, and preventive maintenance for inspection equipment.
• Create, update, and retire defects and defect sets for various container systems, maintaining the Defect Master Library aligned with risk assessments.
• Develop and oversee manual inspection baseline sets to measure sensitivity, ensuring compliance to classification protocols.
• Design, conduct, and maintain training and qualification programs for manual inspectors focused on defect detection and regulatory techniques.
• Supervise manual baseline studies and utilize statistical analysis to set inspection performance benchmarks, maintaining associated documentation.
• Ensure compliance with regulatory bodies such as FDA, HPRA, EMA, Ph Eur, USP, and JP related to visual inspection requirements, and serve as the site SME during regulatory audits.
• Collaborate cross-functionally with Product Supply, Manufacturing, QA, Engineering, and equipment suppliers on inspection matters, supporting change controls, CAPAs, and continuous improvements.

Candidate Profile

• Experience in pharmaceutical inspection operations with a strong background in lyophilisation and/or biologics (mAbs) production environments.
• A Bachelor’s degree in Engineering, Science, Pharmacy, or related field required; Master’s preferred along with pertinent certifications in inspection or pharmaceutical manufacturing.
• Proven experience managing defect libraries and applying statistical methods to inspection baseline studies.
• Project management skills particularly in equipment qualification and inspection process enhancements.
• Demonstrated ability to support regulatory inspections effectively as an SME.
• Must meet Sanofi’s visual qualification criteria including corrected 20/20 vision, depth perception, color deficiency testing, and maintain annual eye exams to perform detailed inspections in controlled environments.

Why Work with Us

• Join a global leader committed to delivering transformative healthcare solutions worldwide.
• Opportunity to develop professionally and explore cross-functional roles in a supportive environment.
• Contribute to accelerating product launches and improving patient access to treatments.