Job description
Context
Assignment within the Production Process – B7 (Biologics).
Strong need on Downstream Processing (DSP) production deviations, with a significant backlog to manage.
New role within the organization: the consultant will report directly to the Hiring Manager or the DSP Production Manager.
Mission is 100% focused on deviation management.
Key Responsibilities
End-to-end management of DSP production deviations, from opening to closure.
Field investigation:
Regular presence in production areas.
Conducting interviews with technicians and operators.
Understanding and challenging equipment functioning and process steps.
Writing of deviations in the Quality System (minor, major, clustered deviations).
Close collaboration with cross-functional teams:
Production teams
QA / QA Validation
MSAT / QAMSAT
Maintenance / Technical Services
Participation in root cause analysis (RCA) and definition of corrective and preventive actions (CAPA).
Defense and explanation of technical analyses in front of QA and other stakeholders.
Expected performance:
Approx. 5 deviations closed per week (mix of minor and major deviations).
Typical Day
Review and analysis of newly opened deviations.
On-the-floor presence: interviews with technicians and key stakeholders.
Technical investigations on equipment and processes to identify root causes.
Drafting, follow-up, and closure of deviations in the Quality System.
Continuous interaction with QA and Production to align on analyses, actions, and timelines.
Profile Requirements
Must Have
4–6 years of experience in a similar role in the pharmaceutical / biologics industry.
Proven experience in writing and managing production deviations (end-to-end).
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
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.
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!
