Expert Assurance Qualité Qualification (F/H/X)

AbbVie · Nouvelle-Aquitaine, France

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Role summary

AbbVie seeks a Quality Assurance Expert for Computerized Systems Qualification at its Martillac site. The role involves organizing and executing GMP-compliant qualification activities, managing deviations and CAPA procedures, and ensuring regulatory compliance through audits and inspections.

What they're looking for

Engineering degree in Quality Assurance or IT Systems Validation, or equivalent pharmaceutical experience
Minimum 5 years professional experience in GMP/BPF Quality Assurance roles
Professional-level English language proficiency
Strong organizational, analytical, and synthesis capabilities
Excellent written and oral communication skills for diverse stakeholders
Ability to work effectively in matrix environments with competing priorities

What you'll be doing

Verify raw data quality and review/approve GMP-related documentation for qualification activities
Review and approve computerized systems qualification strategies and ongoing monitoring from QA perspective
Lead deviation management, investigations, CAPA actions, and changes related to qualification monitoring
Maintain qualified status of computerized systems and ensure GMP compliance recommendations
Participate in preparation, execution, and follow-up of group audits and regulatory inspections

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