Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 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

Mission Description:

We are seeking a dedicated and skilled Quality Assurance (QA) Engineering Specialist to join our team. In this role, you will support the Quality Assurance Engineering department in ensuring that all qualification-related regulatory and procedural requirements are met throughout the complete life cycle of manufacturing and laboratory systems, including the concept, project, operational, and retirement phases.

Key Responsibilities:

Review and approve qualification documents and quality records, including SOPs, user requirements, impact/risks analyses, Test Plans, test scripts, change controls, and CAPAs, to maintain compliance with regulations, guidelines, and policies and standards. Collaborate with engineering teams and interact with other groups to facilitate the introduction of new or upgraded systems and processes. Provide advice and support for the preparation of qualification-related activities while ensuring adherence to cGMP aspects. Address and follow up on deviations that occur during the execution of qualification activities. Communicate the status of quality and compliance, planning, and other relevant updates to QA Qualification team members.

Profile Requirements:

Experience: Proven experience in the chemical and/or pharmaceutical industry, specifically related to the qualification of equipment. Knowledge: Strong understanding of cGMP regulations and guidelines. Communication Skills: Ability to translate technical information into understandable terms for all levels of the organization. Decision-Making: Capacity to accurately assess the urgency, criticality, and impact of decisions related to the function. Multi-tasking: Ability to manage multiple projects simultaneously. Independence: Capability to work independently and within a cross-functional team environment. Language Proficiency: Fluent in English and Dutch (both written and spoken).

Specific Knowledge:

Familiarity with manufacturing and laboratory systems used within the pharmaceutical or chemical industry. Experience with problem report and change request systems (e.g., Trackwise, Comet). Knowledge of document management systems (e.g., TruVault). Proficiency in test tools (e.g., Kneat).

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.