Lead Inspection SME: AVI & MVI Systems

Sanofi

Munster

On-site

EUR 90,000 - 120,000

Full time

33 hours ago

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Job summary

Sanofi Waterford seeks an Inspection Subject Matter Expert (SME) to provide technical authority over visual inspection processes for AVI and MVI, ensuring qualification, compliance, and optimization across Lyo and mAbs operations at the Waterford site.

Reporting to Product Supply APU, the role leads qualification lifecycles, training, defect library management, and regulatory readiness, maintaining 100% visual inspection in line with cGMP and HPRA/FDA/EMA expectations.

Qualifications

Significant pharma experience focusing on inspection operations.
Experience with regulatory inspections (HPRA, FDA, EMA) in an SME capacity.
Background in defect management and 100% visual inspection requirements.
Knowledge of qualification lifecycle for inspection systems and quality standards.

Responsibilities

AVI System Management and site technical authority for AVI equipment across Lyo and mAbs areas.
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.
Defect Set Creation & Management and maintenance of the Defect Master Library (DML).
Train inspectors; qualify inspectors and maintain qualification records.
Ensure compliance with FDA, EMA, HPRA, USP and other regulatory standards.