Inspection Subject Matter Expert - Visual Inspection Lead

Sanofi Inc.; Waterford; On-site; GBP 77,000 - 103,000; Full time

Job summary

Sanofi Waterford is seeking an Inspection Subject Matter Expert (SME) to serve as the technical authority for all visual inspection processes across AVI and MVI. You will lead qualification lifecycle, maintain defect libraries, and train inspectors to ensure 100% visual inspection of injectable products in line with regulatory standards.

Based at on-site Waterford, you will collaborate with Product Supply, Manufacturing, QA and Engineering, drive continuous improvement, support regulatory

Qualifications

• Significant experience in pharmaceutical inspection operations.
• Bachelor's degree in a technical field; a Master's is preferred.
• Experience with lyophilisation or biologics (mAbs) advantageous.
• Familiarity with regulatory inspection processes and global quality standards.
• Ability to manage qualification lifecycles and defect libraries.

Responsibilities

• Lead AVI system qualification lifecycle (URS/FRS, DQ, IQ, OQ, PQ, PPQ).
• Create/update/decommission defects and manage the Defect Master Library (DML).
• Design and deliver training for manual inspectors and maintain qualification records.
• Supervise manual baseline studies and apply statistical analysis for performance benchmarks.
• Ensure 100% visual inspection of all injectable products per FDA/EMA/HPRA expectations.
• Collaborate across Product Supply, Manufacturing, QA and Engineering.

Skills

Inspection operations

Project management

Statistical analysis

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree in Engineering/Science/Pharmacy

Master's degree preferred

Certifications in inspection/quality systems (advantageous)

Tools

AVI systems

Defect library management

Statistical analysis software

Job description

Sanofi Waterford is seeking an Inspection Subject Matter Expert (SME) to serve as the technical authority for all visual inspection processes across AVI and MVI. You will lead qualification lifecycle, maintain defect libraries, and train inspectors to ensure 100% visual inspection of injectable products in line with regulatory standards.

Based at on-site Waterford, you will collaborate with Product Supply, Manufacturing, QA and Engineering, drive continuous improvement, support regulatory