Inspection Subject Matter Expert
Listed on 2026-09-25
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Title:
Inspection Subject Matter Expert (SME)
Location:
Waterford, Ireland Job Type: Permanent, Full-Time Working Arrangements:
On-site
The Inspection SME serves as the primary technical authority for all visual inspection processes at Sanofi Waterford, spanning both Automated Vision Inspection (AVI) systems and Manual Visual Inspection (MVI). Reporting into the Product Supply APU as the process-owning function, this individual will provide expert oversight across the Lyo and mAbs operational areas, ensuring inspection processes are qualified, compliant, and continuously optimised in line with Sanofi global standards and applicable regulatory requirements.
The SME will be the site's technical lead for inspection system lifecycle management, from equipment qualification through to defect library management, inspector training, and baseline study execution, ensuring that all injectable products undergo 100% visual inspection in accordance with cGMP standards as required by the HPRA, FDA, and EMA.
Lead full qualification lifecycle (URS, FRS, DQ, IQ, OQ, PQ, PPQ) of AVI systems
Establish and maintain tuning parameters and challenge set protocols
Manage equipment requalification, log books, and preventive
maintenance programmes
Maintain the site Defect Master Library (DML) aligned with FMEA outputs
Oversee generation of Manual Inspection Sensitivity/Baseline Sets Manage defect classification (Critical, Major, Minor) per site procedures
Train on defect identification, classification, and regulatory inspection techniques
Qualify inspectors and maintain qualification records
Ensure compliance with regulatory standards (lighting, technique, duration)
Lead generation of Manual Inspection Sensitivity/Baseline Sets Apply statistical analysis to establish inspection performance benchmarks
Generate and maintain FMEA documentation
Technical Standards Ensure compliance with FDA, EMA, Ph Eur, USP, and JP inspection requirements
Maintain current knowledge of evolving regulatory expectations
Support regulatory inspections as site inspection SMEEnsure 100% visual inspection of all injectable products
Support change control, deviation investigations, CAPAs, and continuous improvement initiatives
- Significant experience in the pharmaceutical industry, with a significant focus on inspection operations
- Bachelor's degree in Engineering, Science, Pharmacy, or related technical discipline;
Master's degree preferred; relevant professional certifications in inspection, quality systems, or pharmaceutical manufacturing advantageous - Experience in lyophilisation and/or biologics (mAbs) manufacturing environments
- Familiarity with Sanofi inspection procedures and global quality standards
- Experience with defect library creation, management, and decommissioning processes
- Background in statistical analysis as applied to inspection baseline studies
- Project management experience, particularly in equipment qualification or inspection process improvement projects
- Experience supporting regulatory inspections (HPRA, FDA, EMA) in an SME capacity
- Must meet Sanofi SME visual qualification standards, including 20/20 vision (corrected acceptable), adequate depth perception, colour deficiency testing, annual eye examination, and the ability to perform detailed visual inspection tasks in a cleanroom/controlled manufacturing environment.
Transform lives worldwide by delivering life-changing treatments anywhere, anytime. Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride. Help deliver 30+ new product launches by 2030, ensuring
patients get treatments faster than ever. Develop new skills, explore cross-functional roles, and work in an environment that…
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