Job description

As a Qualification & Validation Consultant you will get the chance to work in a multi-national environment and develop your expertise by working on diverse projects.

ROLES & RESPONSIBILITIES

Reporting to the project leader and working in close collaboration with a team of Qualification and Validation experts, you will have the following responsibilities:

• Create user requirements (URS)
• Define the validation strategy based upon the clients’ guidance and benchmarks
• Build validation and qualification plans
• Coordinate and perform FAT/SAT as well as equipment commissioning
• Execute tests (IQ/OQ/PQ/DQ)
• Coordinate and review the related GMP documentation needed for change control
• Ensure the planning of validation and qualification strategies in accordance with all the concerned parties (production/QA/maintenance)
• Ensure the operational management of the technicians dedicated to the validation
• Maintain equipment to support GMP manufacturing
• Foster innovation and continuous improvement on process, and on qualification and validation projects

THE IDEAL PROFILE

• You hold at least a master’s degree in engineering, bioengineering, biology, pharmacy or related fields.
• You hold at least one year of experience in qualification / validation in GMP environment.
• You are familiar with the processes and legal requirements for pharmaceutical industry.
• You have technical understanding of manufacturing equipment (autoclaves, washing machines...) and processes specific to Pharmaceutical manufacturing preferred.
• You are familiar with creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ).
• You are proactive, have good communication skills, and can work in a multidisciplinary team towards a common goal.
• You are proficient in French and English. Dutch is a plus.

6 advantages of joining Amaris Consulting:

• An international learning environment where you can develop your knowledge on different subjects and areas.
• In-depth training so that you can gain more technical skills.
• Certifications that will allow you to gain a competitive edge.
• An R&D Lab that will give you the opportunity to develop your skills that you can then use on innovative projects
• Opportunity to pitch your ideas to help us grow a successful business
• Regular coaching and mentoring provided by our Senior Technical Consultants who will allow you to become, in turn, an expert in your profession.
• An attractive, tailor-made and evolving career path

What about my salary?

It all depends on your profile and your skills, but we offer a fixed salary in line with the market and scalable throughout your career with us.

Most importantly, you'll be part of an independent company that values:

Agility: we are flexible, dynamic and offer a stimulating environment.

International: daily international exchanges and mobility opportunities around the world.

Intrapreneurship: if you want to invest in related topics or develop a Business Unit, Amaris is for you!

Supportive Leadership: with a limited number of consultants, your manager will adapt to your profile and accompany you throughout your professional journey!

Still not convinced ? Because we are committed to giving meaning to our daily actions, Mantu is committed to sustainability (reduction of our carbon footprint, collaboration with various associations, diversity and inclusion policy).