Senior QA Engineer

Vulcain Engineering Belgium is looking for a Senior QA Engineer to join its team in Liège.

As a Senior QA Engineer , you will ensure that the products fully meet customer and regulatory requirements related to both products and manufacturing processes.

ABOUT THE POSITION :

• Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
• Manage quality systems, e.g. change control, deviations, and product investigations.
• Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products meet GMP requirements.
• Review batch abstracts to release products in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
• Interact with multi-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and handle schedule and/or process-related conflicts.
• Demonstrate understanding of applicable regulations related to the manufacture of medicinal products (biologics).
• Manage notification flows in quality systems between internal and external partners
• Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.

ABOUT YOU :

• You hav e a Master’s degree in life sciences, biotechnology, pharmaceuticals, or any relevant engineering field
• You have at least 8 years of experience
• You have a good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context
• You understand and know how to work i n a GMP environment
• You are fluent in French and you have a professional level of English

ABOUT US :

Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.

In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:

• Energy/Infrastructure
• Gas Renewables & Processes
• Life Sciences

With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.

Why would you apply?

• A competitive package including gross salary paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus
• A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
• A human-based company with slightly more than 120 consultants and synergies between the different busin ess units