Responsable assurance qualité

Vulcain Engineering Belgium is looking for a QA Engineer to join its consulting team.

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:

• Bachelor’s or Master's degree and between 3 and 5 years of experience in a cGxP or other regulated environment, including 1 year in a quality role
• Excellent communication and organizational skills
• Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time)
• Fluency in English and French is mandatory for the position

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 offices based in Brussels, Leuven, and Ghent, 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 ranging from €44,000 to €55,000 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. (The salary indicated corresponds to the level of experience mentioned in the job description. For any other level of experience, the annual salary may vary accordingly).
• 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 business units