QC Specialist

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique Real Staffing Temps plein

We are seeking a highly skilled and experienced QC Biologics Specialist to join our dynamic team. In this pivotal role, you will support the implementation of biologics-based product projects from phase III through the entire product lifecycle. Your scientific expertise and experience will be crucial in managing deviations, investigations, and change controls, as well as tracking and managing samples. You will work closely with team leaders and technicians, ensuring smooth communication and coordination within the Quality Control lab. If you are passionate about quality control in the bio-pharmaceutical industry and excel in a collaborative, fast-paced environment, we encourage you to apply and be a part of our innovative journey.

Our client is a leading global bio-pharmaceutical company dedicated to improving patient outcomes through innovative biologics-based therapies. With a strong commitment to scientific excellence and rigorous quality standards, they are at the forefront of developing life-changing treatments. Their collaborative and dynamic work environment fosters growth, innovation, and the highest level of professional integrity. Join this prestigious organization and contribute to their mission of advancing healthcare worldwide.

QC Biologics Specialist

Mission Description: The QC Biologics Specialist will support the implementation of biologics-based product projects from phase III through the lifecycle of the product, leveraging scientific expertise and experience. Key expectations include:

  • Providing support to the management team of the QC Biologics laboratory.
  • Communicating internal urgencies and priorities within the Quality Control lab team and adjusting planning with Team Leads.
  • Tracking samples (release, in-process, stability) from reception to destruction.
  • Handling deviation, investigation, action items, and change controls.
  • Supporting the implementation and updates of methods, including documentation redaction and training of operators.
  • Supporting product launches, including data sharing with authorities and updates of batches and sampling plans.

Mission Responsibilities:

  • Support GMP activities in the laboratory, including sample tracking through GMP systems.
  • Actively participate in meetings with production/MSAT for close coordination with the laboratory.
  • Update/review laboratory documentation, including analytical methods, analytical instructions, and coaching modules.
  • Manage deviation and investigation treatments, ensuring follow-up on corrective and preventive actions.
  • Create and follow up on change controls.
  • Support product launches and prepare documentation requested by authorities.

The QC Biologics Specialist will report to the Head of Laboratory and work closely with Team Leaders and technicians of the laboratory.

Specific Professional/Technical Expertise and Key Skills Required:

Education:

  • Master's degree in Analytical Chemistry (applied to biological products/NBE), Biochemistry (CBA, PCR, Elisa, etc.), Biology, or equivalent.

Experience:

  • Minimum of 5 years of expertise in pharmaceutical analysis of biological products, specifically monoclonal antibodies, in a similar position.
  • Experience in a QC GMP environment is required.
  • Strong organizational skills with proven records.
  • Proven leadership skills, including planning, monitoring, decision-making, and reporting.
  • Proven experience in documentation creation and updates to support QC activities.
  • Proven experience in managing deviations and investigations in collaboration with QA, Team Leaders, and technicians.

Specific Skills:

Communication:

  • Ability to communicate smoothly with technicians, managers, and stakeholders.
  • Ability to lead and influence people in a complex matrix environment.
  • Ability to manage interfaces with stakeholders (development, quality assurance, and analytical product owner).
  • Presentation and meeting facilitation skills.
  • Fluency in English and French.

Continuous Improvement/Problem Solving:

  • Proactively identify and address potential problems or areas for improvement and act on them in a problem-solving manner.
  • Act as a facilitator.
  • Lead investigation/deviation to support manufacturing and laboratory investigations with our laboratories.
  • Business-driven with a view to overall strategy.

Organization:

  • Ability to organize multiple requests and manage priorities.
  • Strong sense of accountability and responsibility.
  • Ability to work collaboratively with technicians and managers.
  • Customer and results-oriented.

Main Responsibilities:

  • Support the increase in laboratory capacity with a team of nearly 50 people, including analysts and specialists.
  • Cross-functional coordination: Work with Team Leaders to manage deviations, investigations, and priorities, ensuring smooth communication with different teams, especially during urgent situations.
  • Sample management: Track samples using tools like LIMS, coordinate their reception, testing, and release, ensuring compliance with client deadlines.
  • Manage deviations, root cause analyses, investigations, and changes related to processes with precision.
  • Manage documentation related to validations, analyses, and regulatory authority requests.
  • Ensure timely follow-up of urgent analytical requests, ensuring tests are performed within specified deadlines.
  • Handle various and sometimes complex requests from internal and external clients (in both English and French).

Skills and Qualifications:

  • Ideally, 5 years of experience in a quality control or laboratory environment (experience in chemistry, biochemistry, or a similar field is a plus).
  • Experience in root cause analysis, managing investigations, and change control.
  • Proficiency in LIMS and laboratory-specific process tools.
  • Ability to work in a dynamic environment with urgent requests, demonstrating strong stress management skills.
  • Proven communication skills, both in French and English, internally with the team and with external clients.
  • The position is site-based, with the possibility of remote work up to two days a week, depending on team needs and priorities.
  • Teamwork is essential, with a strong collaborative dynamic between QC teams and other departments.
  • The work takes place in a bio-pharmaceutical environment, with strict compliance and quality requirements.

Desired Qualities:

  • Team spirit: Ability to collaborate effectively with various levels of hierarchy and integrate feedback to improve processes.
  • Priority management: Ability to manage priorities and adapt to a constantly evolving environment.
  • Positive attitude: Solution-oriented mindset and the ability to remain calm in high-stress situations.

Academic Experience:

  • A master's degree or equivalent in a relevant field is appreciated, but experience and a proactive mindset are more important.
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