Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!

Job Description

The Position

Your role will involve the review and approval of qualification and requalification activities related to Facilities and Utilities (F&U) and Process Equipment key responsibilities include:

• Collaboration with MAM and E&PS Departments: Ensure the qualification status of critical production assets by identifying, qualifying, and controlling system critical aspects related to facilities, utilities, product, and process requirements. Evaluate and investigate equipment issues impacting quality and compliance, and implement corrective and preventive actions.
• Manufacturing Department Coordination: Approve new change controls and ensure thorough investigation and resolution of deviations impacting quality and compliance.
• Quality Organization Connectivity: Build strong relationships with various quality organizations.
• Compliance Management: Review and approve procedures such as calibration rationales, master forms, completed calibration records, master data setup, maintenance plans, and daily operations activities. Ensure data integrity through system audit trail and user access reviews.
• Approval of Qualification Documents: Approve qualification documents including change controls, master documents, protocols, reports, SOPs, URS, IA, QSR, and manage discrepancies and corrective actions during qualification activities.
• Participation in Improvement Projects: Engage in system and process optimization projects, ensuring quality and compliance aspects are maintained. Stay updated on international regulations, guidelines, and industry practices, and become the QA process expert.
  
  
  

Qualifications

• Educational Background: Master’s degree in engineering with a chemistry or analytical background, or in pharmaceutical sciences.
• Quality Awareness: Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing cell therapy products. Ability to defend strategies and documents during health authority inspections.
• Affinity with Computerized Systems: Experience with system parameter configurations and data management in critical production assets.
• Communication Skills: Strong communication skills and ability to work cross-departmentally in a continuously changing environment.
• Language Proficiency: Fluent in Dutch and English, both orally and in writing.
• Analytical Thinking: Strong analytical thinking, risk assessment, and communication skills.
• Collaboration Skills: Proven ability to collaborate and work effectively in teams.
  
  
  

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.