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:
o Regular presence in production areas.
o Conducting interviews with technicians and operators.
o 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:
o Production teams
o QA / QA Validation
o MSAT / QAMSAT
o 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.