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;
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