Spécialiste 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 dry form products and packaging. The role involves representing the Quality Assurance department within project teams to ensure compliance with qualification policies and quality standards throughout the project lifecycle. You will manage quality systems, perform risk analyses, and oversee the qualification documentation for new equipment.

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 required for facility commissioning.
• Participate in project follow-up meetings and represent Quality Assurance to stakeholders.

Required skills

• Quality Assurance
• Qualification and Validation
• Pharmaceutical Industry
• GMP
• Risk Analysis
• Change Control
• CAPA
• Technical Writing
• English

Nice to have

• Dry form processes
• 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 passion for science with teamwork to redefine excellence in the life sciences sector. They offer an integrated service model including consulting, Functional Service Provider, and Full Service, fostering a collaborative and inclusive environment.