Ingénieur Assurance Qualité Projets

About the role

Excelya is seeking a Quality Assurance Project Engineer to support strategic pharmaceutical projects, specifically focusing on the transfer of solid dosage forms and packaging. The role involves representing the Quality Assurance department within project teams, managing qualification and validation strategies, and ensuring compliance with quality systems throughout the project lifecycle.

Responsibilities

• Represent Quality Assurance within project teams and ensure the application of qualification policies for new equipment.
• Define and draft quality documentation including user requirements, specifications, validation master plans, and associated reports.
• Manage the quality system at the project level, including Change Controls, CAPA, deviations, and document management.
• Conduct criticality and risk analyses related to equipment and systems.
• Draft and review qualification documentation such as FAT, SAT, IQ, OQ, PQ, and PV.
• Participate in field qualification execution in collaboration with user and engineering teams.
• Review and contribute to the drafting of procedures and operational documents for facility commissioning.
• Participate in project follow-up meetings and represent Quality Assurance to stakeholders.

Required skills

• Quality Assurance
• Qualification and Validation
• Pharmaceuticals
• GMP
• Change Control
• CAPA
• Risk Analysis
• Documentation
• English

Nice to have

• Solid dosage forms
• Extrusion
• Granulation
• Compression
• Packaging

Qualifications

• Engineering degree
• Pharmacist degree
• Equivalent scientific or technical education

About the Company

Excelya is an ambitious healthcare company that combines consulting, Functional Service Provider, and Full Service models to support major players in the Life Sciences sector. The company fosters a collaborative environment focused on audacity, benevolence, and energy.