CMC Quality Solutions Specialist

  • Location: Brabant Wallon, Région wallonne, Belgique
  • Job #27289

CMC Quality Solutions Specialist

Contracting – Brabant Wallon

Your responsibilities:

  • Preparing and coordinating Change Control Committee meetings (documentation review, ensuring readiness).
  • Supporting QMS maintenance: follow‑up of changes, documentation updates.
  • Managing deviations: creation and follow-up.
  • Performing QRR assessments for product launches to ensure compliance with regulatory requirements.
  • Collecting and consolidating relevant information for MedInfo questions.
  • Taking meeting minutes, asking the right questions, challenging stakeholders with solid QA arguments.
  • Supporting transversal initiatives (process improvements, QA–RA alignment).
  • Building and maintaining product QA knowledge (SharePoint, documentation).

Your profile:

  • Minimum 6 years of experience (flexibility if slightly below, e.g., internships may help but not fully replace).
  • Strong experience in pharmaceutical or biotech industry is preferred.
  • Experience in operations/production is a strong plus.
  • Fluent English & French
  • Strong Quality Assurance mindset and QA background.
  • Ability to understand scientific/technical discussions (even if scientific ownership stays with the CMC Lead).
  • Experience in GMP / QA processes (change control, deviations, QMS support).
  • Ability to handle pushback, challenge stakeholders, and defend QA standards with solid arguments.
  • Excellent communication & coordination skills.
  • Ability to work autonomously, analyze data, and make decisions.
  • Good comprehension of regulatory/CMC requirements.

Nice to have:

  • Experience in Data Integrity (mindset more important than hands‑on reporting).
  • Experience in GMP audits & inspections.
  • Project management skills.
  • Background in production/manufacturing to better understand operational partners.
  • Knowledge of biologics + small molecules (products can be pharma or bio).
     

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]

 

Microbial Colony Counting and AI Support

  • Location: Brabant Wallon, Région wallonne, Belgique
  • Job #26711

Microbial Colony Counting and AI Support

Contracting – Brabant Wallon

Your responsibilities:
We are seeking a motivated and detail-oriented Contract Worker to support the evaluation and assessment of supplier solutions related to microbial colony counting. This role involves contributing to the testing phase, generating comprehensive reports, supporting the evaluation of AI algorithms, and performing image labeling tasks. The ideal candidate will be a quick learner, able to work collaboratively within a team, and demonstrate autonomy.

  • Assess and evaluate supplier solutions for microbial colony counting, ensuring accuracy and reliability.
  • Conduct testing phases and document findings in detailed reports.
  • Provide support in testing and evaluating AI algorithms for image analysis and related data.
  • Perform precise image labeling and annotation tasks to support AI-driven solutions.
  • Collaborate with team members across departments to share insights and ensure alignment of objectives.
  • Adapt quickly to new tools, technologies, and methodologies essential for the role.
  • Maintain a high level of autonomy while managing tasks and delivering results within deadlines.

Your profile:

  • Proficiency in French and English (both written and spoken).
  • Educational background in life sciences, microbiology, computer science, or a related field (or equivalent experience).
  • Familiarity with microbial colony counting processes and laboratory testing methods.
  • Basic understanding of AI algorithms and their applications in image analysis.
  • Experience with image labeling tools or software is a plus.
  • Excellent analytical and problem-solving skills.
  • Ability to work collaboratively within a team while demonstrating independence and initiative.
  • Adaptability to learn and apply new technologies and methodologies quickly.

Preferred Qualifications:

  • Previous experience in microbial research or AI-based image analysis projects.
  • Knowledge of supplier solution assessments or vendor management.

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]