QC Biologist Specialist
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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
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Education:
Master's degree in Analytical Chemistry (applied to biological products / NBE), Biochemistry (CBA, PCR, Elisa, etc.), Biology, or equivalent.
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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. Are you ready to take on this challenge and drive quality forward? Feel free to reach out or apply directly or contact : mehdi.soli.soli@randstad.be
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