QA Specialist

Thermo Fisher Scientific

  • Seneffe, Hainaut
  • CDI
  • Temps-plein
  • Il y a 17 jours
Work Schedule Standard Office Hours (40/wk)Environmental Conditions OfficeJob DescriptionAs a QA Specialist, you will act as a key Quality partner for cross-functional teams (including Manufacturing, QC, Validation, Technical Services, Supply Chain, and R&D), ensuring strict adherence to GMP requirements and internal procedures. Your role is central to operational compliance, coaching, documentation oversight, and regulatory readiness. With deep expertise in quality systems and a hands-on approach, you are a trusted resource for the business.Key Responsibilities
  • Serve as the primary QA point of contact for assigned operations, ensuring compliance with GMP standards and internal procedures.
  • Ensure data integrity and traceability in digital and paper systems (e.g., SAP, LIMS, TrackWise, Discoverant).
  • Approve creation of new GMP article codes, ensuring alignment with procedures and systems.
  • Coach operational teams in GMP standard methodologies, translating regulatory requirements into practical mentorship.
  • Review and approve GMP documentation (batch records, validation reports, sampling plans, specifications, calibration records, BOMs, MBRs, etc.).
  • Coordinate QA elements of batch release, including BR assessments and raw material release without QC testing.
  • Participate in and lead on-site audits and inspections (internal, external, regulatory), representing QA topics and documentation.
  • Support deviation, CAPA, and change control investigations and ensure timely and thorough documentation.
  • Maintain QA oversight of equipment qualification, process validation, and environmental compliance in GMP areas.
  • Contribute to continuous improvement initiatives, document lifecycle management, and GMP training.
  • Promote teamwork and positive attitude
Qualifications
  • Master’s degree in Biology, Biochemistry, Chemistry, or a related scientific field.
  • Thorough with strong documentation and problem-solving abilities.
  • Strong working knowledge of SAP and LIMS (asset).
  • At least 5 years of experience in pharmaceutical QA, preferably in an aseptic manufacturing environment.
  • Proven experience working in GMP-regulated environments.
  • Fluent in French and English (spoken and written).
  • Excellent communication, analytical, and coaching skills.
What We Offer
  • A dynamic, multi-product biopharmaceutical site supporting both clinical and commercial manufacturing.
  • A collaborative and empowering work culture focused on innovation, compliance, and quality excellence.
  • Opportunities for professional development and cross-functional exposure.
  • The chance to contribute directly to the safety and efficacy of life-changing therapies.

Thermo Fisher Scientific