QA Qualification Engineer

Expleo offers a unique range of integrated engineering, quality, and strategic consulting services for digital transformation. Against a backdrop of unprecedented technological acceleration, we are the trusted partner for innovative companies. We help them develop a competitive advantage and improve the daily lives of millions of people.

We are looking for a :

Responsibilities:

The QA Qualification Engineer is ensuring that all processes for equipment and systems qualification/validation comply with cGMP requirements and internal/external quality standards over the entire life cycle.

• Analyse and liberate qualification reports and SOPs.
• Support and supervise proper qualification of equipment suppliers.
• Possess all quality correlated tasks for the commissioning and qualification (C&Q) actions of devoted new amenities, tools and utilities in relation to GMP manufacturing of biologics & APIs
• Ensure proper qualification of equipment/instruments/computerised-systems and staff by making certain the corresponding VMP(s) and GMP guidelines.
• Establish and maintain Equipment Qualification System at Drug Product Services for both manufacturing equipment and analytical instruments.
• Be a Subject Matter Expert (SME) and provides guidance and recommendations to internal or external customers.

Profil :

• Minimum 4 years experiences in biotechnologie
• Minimum 1 year as QA Qualification/Validation
• Knowledge on IQ, OQ, PQ, SIP
• Knowledge on (at least 2 of them) USP/DSP process, Autoclave, FIT, Welding device, CIP, Utilities distribution
• English mandatory, French is a plus
• Team Spirit, Positive mindset, pragmatic, multitasking