Spécialiste Assurance Qualité - Conformité des Projets / Quality Assurance Specialist - Project Compliance
Core
Independent quality and compliance oversight for strategic site and product projects across the full lifecycle, from new product introduction through technology transfer, validation, commercialization, and routine commercial manufacturing.
Role type
Quality Assurance Specialist (Project Compliance)
Builds
Pharmaceutical and biotechnology products for consumers and patients
Domain
Pharmaceutical manufacturing and regulatory compliance
Required skills
GxP/GMP compliance, risk management, validation protocols, regulatory inspection readiness, CAPA management, quality system governance, data integrity, new product introduction, technology transfer, FDA/Health Canada/ICH/PIC/S/NMPA regulations
Preferred skills
Master's degree, experience with Rx/OTC/cosmetics, global regulatory environments
Technologies
None stated
Responsibilities
Act as QA representative for compliance, validation, technology transfer, new product introduction, and remediation projects; Provide independent QA oversight to ensure GMP/GxP, regulatory, validation, product quality, and data integrity compliance; Lead and facilitate quality risk management activities; Review and approve risk assessments, validation protocols/reports, and QA documentation; Support new product introductions, technology transfers, and commercial launches; Identify compliance gaps and drive CAPA, change controls, investigations, and remediation; Support regulatory inspection readiness, internal/external audits, and health authority inspections; Contribute to continuous improvement of quality systems.
Seniority
Mid-Senior, hands-on IC
