Ingénieur Assurance Qualité Projets

About the role

Excelya is seeking a Quality Assurance Project Engineer to support strategic pharmaceutical projects, specifically focusing on incoming product transfers for dry forms and packaging. The role involves representing Quality Assurance within project teams, managing qualification strategies, and overseeing quality systems throughout the project lifecycle. You will ensure compliance with regulatory standards while collaborating with engineering and user teams to validate equipment and processes.

Responsibilities

• Represent Quality Assurance within project teams and ensure application of qualification policies for new equipment.
• Define and draft project-related quality documentation including user requirements, specifications, validation master plans, and reports.
• Manage project-level quality systems including Change Controls, CAPA, deviations, and documentation.
• Conduct criticality and risk analyses for 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 quality documents.
• Participate in project follow-up meetings and represent Quality Assurance to stakeholders.

Required skills

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

Nice to have

• Dry forms processing
• 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 deliver high-value projects in the Life Sciences sector. The company fosters a collaborative environment centered on boldness, kindness, and energy, promoting diversity and inclusion.