QC Biologist Specialist

Randstad Belgium; Waals-Brabant; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Randstad Belgium in Walloon Brabant seeks a QC Biologist Specialist for a pharmaceutical company on a 6-month project. You will provide scientific expertise in biologics QC, supporting implementation from Phase III through the product life cycle and ensuring smooth lab operations.

Required are a Master’s degree in Analytical Chemistry / Biochemistry / Biology, 5+ years in pharma biologics QC, GMP knowledge, and strong documentation/leadership skills. Fluent English and French are essential.

Qualifications

• Minimum 5 years in a similar QC/biologics role.
• GMP knowledge in a QC GMP environment is mandatory.
• Strong documentation creation/updating, planning, monitoring and QA collaboration.

Responsabilités

• Manage end-to-end sample tracking (release, in-process, stability) through GMP systems.
• Handle deviations, investigations, CAPAs, and change controls.
• Ensure smooth internal communication regarding urgencies and priorities with Team Leads and stakeholders.
• Participate in meetings with Production and MSAT teams for lab coordination.
• Update and review laboratory documentation, methods, and coaching modules.
• Support product launches, new process implementations, and prepare documentation for authorities.

Connaissances

Leadership

Organizational skills

Problem-solving

Analytical mindset

Communication

Fluent English

Fluent French

Formation

Master's degree in Analytical Chemistry / Biochemistry / Biology

Description du poste

We are looking for a QC Biologist Specialist for a pharmaceutical company in Walloon Brabant!

If you are an experienced scientific professional with a strong background in biologics and quality control, this 6-month, project-based opportunity might be the perfect fit for you.

About the Role: In this role, you will support the implementation of Biologics-based products from Phase III throughout the product life cycle. Working closely with the QC Biologics management team, Team Leaders, and technicians, you will provide critical scientific expertise and ensure smooth laboratory operations.

Key Responsibilities:

• Manage end-to-end sample tracking (release, in-process, stability) through GMP systems, from reception to destruction.
• Handle deviations, investigations, corrective/preventive actions (CAPAs), and change controls.
• Ensure smooth internal communication regarding urgencies and priorities, adjusting planning with Team Leads and various stakeholders.
• Actively participate in meetings with Production and MSAT teams to ensure close coordination with the lab.
• Update and review laboratory documentation, including analytical methods, instructions, and coaching modules.
• Support product launches, new process implementations, and prepare necessary documentation for authorities (data sharing, batch updates, sampling plans).

Your Profile:

• Education: Master's degree in Analytical Chemistry (applied to biological products / NBE), Biochemistry (CBA, PCR, Elisa, etc.), Biology, or equivalent.
• Experience: Minimum 5 years in a similar position with expertise in the pharmaceutical analysis of biological products, specifically monoclonal antibodies.
• GMP Knowledge: Proven experience working in a QC GMP environment is mandatory.
• Hard Skills: Strong track record in documentation creation/updating, planning, monitoring, and conducting investigations in collaboration with QA.
• Soft Skills: Excellent organizational and leadership skills, stress resistance, continuous improvement mindset, and a problem-solving approach.
• Languages: Fluent in both English and French.

Practical Details:

• Duration: 6 months, starting ASAP.
• Schedule: Full-time (8 hours/day, indicatively 09:00 to 18:00).
• Work Model: Hybrid setup with 3 days on-site in Walloon Brabant and 2 days working from home.