QA Specialist

Vulcain Engineering Group | Belgium; Geel; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Company car & fuel card

Meal vouchers

Insurance

Eco cheques

Sectorial bonus

Representation fees

Job summary

Vulcain Engineering Belgium is seeking a QA Specialist to join its Geel area team. You will provide quality support to operations of a multiproduct facility, ensuring compliance with cGMP and regulatory standards.

You will prepare and review quality documentation, support on-site operations, and contribute to deviation prevention and process improvements, with growth opportunities and trainings.

Qualifications

• Master’s degree in a scientific field or equivalent through experience.
• Knowledge and interpretation of cGMP in a regulated environment.
• Knowledge and understanding of clinical manufacturing and regulations is an advantage.
• Knowledge and experience with Quality Processes and Quality Assurance.
• Excellent accuracy and attention to detail.
• Independent and strong sense of responsibility.
• Enthusiastic team player with strong communication skills.

Responsibilities

• Prepare and review quality documentation in the context of projects (Project notes, Quality plans, …)
• Follow up and review general project documentation (risk assessments, validation plans, procedures, batch records, …)
• Provide quality support and share expertise regarding clinical and commercial manufacturing
• Prepare and review project documentation (procedures, risk assessments) with focus on deviation prevention (DPP) and human error prevention (HEP)
• Ensure compliance with SOPs, global standards, regulations, and product registration related to clinical and commercial manufacturing
• On the floor GMP support, including executing GEMBAs
• Know when QA issues/events need to be escalated to supervisor/manager

Skills

CGMP knowledge

Quality Assurance

Attention to detail

Independent worker

Team player

Communication skills

Clinical manufacturing knowledge

Education

Master’s degree in a scientific field

Job description

Vulcain Engineering Belgium is looking for a QA specialist to join its team in the Geel area.

As a QA Specialist, you will be responsible for providing quality support to the operations activities of a multiproduct facility. Not only will you work on diversified and challenging topics, but we will also support your growth and development through a specific follow-up from one of our Business Managers and the possibility to benefit from specific trainings related to your career objectives.

ABOUT THE POSITION:

• Prepare and review quality documentation in the context of projects (Project notes, Quality plans, …)
• Follow up and review general project documentation (risk assessments, validation plans, procedures, batch records, …)
• Provide quality support and share expertise regarding clinical and commercial manufacturing
• Prepare and review project documentation (procedures, risk assessments) with focus on deviation prevention (DPP) and human error prevention (HEP)
• Ensure compliance with SOPs, global standards, regulations, and product registration related to clinical and commercial manufacturing
• On the floor GMP support, including executing GEMBAs
• Know when QA issues/events need to be escalated to supervisor/manager

ABOUT YOU:

• Master’s degree in a scientific field or equivalent through experience
• Knowledge and interpretation of cGMP in a regulated environment
• Knowledge and understanding of clinical manufacturing and regulations is an advantage
• Knowledge and experience with Quality Processes and Quality Assurance
• Excellent accuracy and attention to detail
• Independent and strong sense of responsibility
• Enthusiastic team player with strong communication skills

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
• 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 business units