Quality assurance expert

Job description:

• Review deviations related to production events within quality systems (e.g. Trackwise) to ensure adherence to standard procedures and regulatory requirements;
• Conduct or approve investigations, impact assessments, and define relevant CAPAs;
• Prepare, evaluate, and approve controlled documentation revisions or creations;
• Attend relevant meetings to support the performance of assigned tasks;
• Respect and follow the escalation process for critical issues;
• Complete relevant training and manage software access in line with company policies;
• Support the team with other conventional quality oversight tasks, such as continuous improvement initiatives, GMP tours, and batch reviews, as needed.

About the customer:

This role is critical in supporting routine GMP operations for the Fill and Finishing area and ensuring compliance with current guidelines, regulatory requirements, and internal standards.

Requirements:

• Fluency in French and English is mandatory;
• Master's degree (or equivalent) in a technical or scientific discipline;
• 2-3 years of operational cGMP experience in a Quality Ops department within a pharmaceutical manufacturing site for sterile injectable products;

Strong holistic understanding of production processes, including:

• Cell culture, aseptic filling, unit operations, equipment, gowning, environmental controls, and laboratory testing (physicochemical and biological). Comprehensive knowledge of Quality standards (cGMP) and Quality systems (deviations, CAPA, change control, training, documentation);
• Strong writing skills for documents in French and/or English;
• Proficient in Microsoft Office and computer-based work;
• Team player with strong agility and autonomy;

Compensation benefits:

• An opportunity to contribute to the quality and compliance of critical operations within a renowned pharmaceutical organization;
• A collaborative work environment with opportunities for professional growth