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    Senior Quality Assurance Engineer Life Sciences

    • On-site, Hybrid
      • Diepenbeek, Limburg, Belgium

    Join SIMABS as a Senior Quality Assurance Engineer to drive GMP excellence, ensure top quality standards, and innovate in biopharma. Your expertise shapes our future. Apply today!

    Job description

    We are SIMABS

    SIMABS is a forward-thinking biotechnology venture dedicated to delivering cost-effective therapeutic monoclonal antibodies to the biopharmaceutical industry. With a focus on simplicity, innovation, and a vibrant start-up culture, we are setting new standards in biopharmaceutical manufacturing. If you’re ready to join a dynamic team and help shape the future of our industry, SIMABS could be your perfect match!

    Job content

    As our Senior Quality Assurance Engineer, you will be a critical part of our quality team. You will ensure the highest quality standards in our processes by combining project-specific QA tasks with day-to-day quality management activities. Your expertise will help maintain and continuously improve our Quality Management System (QMS) while working closely with the Head of Quality.

    Responsibilities:

    Project Quality Assurance

    • Product Implementation: Support the implementation of new products at our GMP site.
    • Technical Reviews: Review and discuss tech transfer data packages and implementation documents.
    • Validation: Prepare and review project-specific validation protocols and reports.

    Routine Quality Assurance

    • Documentation: Draft master batch records and conduct comprehensive batch record reviews.
    • Environmental Monitoring: Support and review environmental monitoring activities.
    • Material Management: Release incoming materials and develop detailed material specifications.
    • Supplier Oversight: Assist in the qualification and requalification of suppliers.
    • Compliance: Ensure strict adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

    Quality Management System (QMS) Maintenance

    • Monitoring: Track and follow up on events, planned deviations, supplier complaints, OOS, CAPA, and change requests.
    • Documentation Management: Write and review SOPs, work instructions, and forms; archive records and files.
    • Collaboration: Prepare documentation for management reviews and collaborate closely with the Head of Quality to enhance our quality processes.

    Job requirements

    • A Master’s degree in Biochemistry, Chemistry, Pharmaceutical Laboratory Technology, or a related field—or equivalent relevant experience.
    • Minimum of 5 years of experience working in a GMP environment.
    • Strong expertise in GMP and Good Documentation Practices.
    • An exceptional eye for detail paired with excellent organizational skills.
    • A proactive, results-driven, and team-oriented mindset.
    • The ability to quickly assimilate and apply new information.
    • Strong, honest communication skills.
    • Flexibility with work hours, including occasional weekends, early mornings, evenings, or nights
    • A start-up mentality that embraces challenges and seizes opportunities.

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