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 quality assurance activities for IT system qualifications, ensuring GMP compliance, and managing deviations, investigations, and regulatory audits.

What they're looking for

Engineering degree in quality assurance or IT systems validation, or pharmaceutical equivalent
Minimum 5 years professional experience in quality assurance under GMP standards
Professional-level English proficiency
Strong organizational, analytical, and synthesis capabilities
Excellent written and verbal communication skills
Ability to work effectively in matrix environments with competing priorities

What you'll be doing

Oversee quality assurance verification of raw data and GMP document reviews for IT system qualifications
Manage deviations, investigations, CAPA, and changes related to qualification activities
Review and approve IT system qualification strategies and monitoring from quality perspective
Maintain qualified status of computerized systems throughout their lifecycle
Participate in group audits, regulatory inspections, and internal audits for IT system qualification

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