Context
Due to a strong increase in production activity, our client’s biopharmaceutical site is facing a high workload in documentation, deviation management, and continuous improvement projects (CAPA, change control, etc.).
To support operations, we are looking for an Operational Support Leads to reinforce the Buffer/Media and Upstream/Downstream production support teams in a fast-paced GMP commercial production environment.
Your Responsibilities
In this role, you will act as a key interface between production and quality, ensuring smooth daily operations and robust documentation practices.
Typical day-to-day activities:
Participate in daily Tier 2 production meetings (KPIs, safety, quality, people)
Join daily deviation meetings (event review, classification, ownership assignment)
Perform batch record review and manage deviations from opening to closure
Support CAPA and change control activities (including weekly follow-up and review)
Contribute to continuous improvement initiatives and operational excellence projects
Coordinate with multiple stakeholders across production, QA, QC, and support functions
Profile
Experience
3–8 years of experience (medior level)
Minimum 3 years of relevant experience in a GMP production environment
Must-have skills
Solid experience in GMP production (Upstream, Downstream, Buffer or Media)
Hands-on experience with deviation management and GMP documentation
Ability to work in a fast-paced, high-demand environment
Strong autonomy, proactivity, and ownership of topics
Excellent communication skills and ease in dealing with multiple stakeholders
Basic understanding of biopharmaceutical production processes
Ideal candidate
Previous experience in GMP commercial production
Comfortable managing deviations end-to-end with limited supervision
Strong critical thinking and problem-solving mindset
Ability to identify quick wins and propose pragmatic remediation actions
Highly adaptable, resilient, and comfortable with change
Strong interpersonal skills and ability to integrate quickly into a team
Nice to have
Experience across both upstream and downstream processes
Exposure to continuous improvement / operational excellence projects
Familiarity with different deviation systems/tools
Hybrid background combining production and documentation/coordination roles
Languages
French: Mandatory
English: Basic level (mainly for documentation; no regular meetings in English)
Working Conditions
On-site presence: ~80% on-site, up to 1 day remote per week
Workload: Full-time (100%) preferred
Some flexibility possible after onboarding, depending on performance
Special weekend role (specific position):
Availability Saturday–Sunday (+ possibly Monday)
Compensatory days off during the week (Tuesday–Friday)
This setup will likely require freelance status
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.