QA Compliance Reviewer

il y a 20 heures


Gent, Belgique TMC Temps plein

Belgium Life Sciences Ghent

Ready to dive into Quality Assurance? Join us to get started with an exciting journey in Pharmaceuticals and Biotechnology
- About The Member Company
- We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud community. We offer consultancy services to high-profile clients globally in diverse service areas, such as:

- Technology & Engineering
- Energy & Renewables
- Life sciences & Pharma
- Digital & IT

**About this vacancy**:
As a QA Compliance Reviewer, you play a key role in ensuring compliance with cGMP’s and SOP’s. You follow up the necessary documentation and communication towards the team.
- You act as the point of contact within the team and provide assistance to other departments on matters of compliance.
- You are punctual in following up on possible issues and change-related documentation.
- You rectify daily deficiencies within reviewed documentation, strictly following cGMPs and SOPs.
- You ensure MES project compliance with procedures and regulations and instigate non-conformance investigations.
- You convey up-to-date status reviews to the team, consistently updating tracking spreadsheets and reports.
- You coordinate with project teams to refine and expedite the batch records cycle time.
- You compile production information for OOS, Deviation, and CAPA logs.
- You ensure the availability of production documents and perform quality review for executed batch records.

**What we expect from you**:

- You have a Master’s degree in Biomedical Sciences, Bioscience engineering, Biochemistry, Industrial Pharmacy,...
- A first experience in a pharmaceutical or biotech environment is a plus.
- You have an eye for detail, strong analytical and problem-solving skills.
- Accuracy in e.g. administration is one of your strong points.
- Fluent in Dutch and English.

**What you can expect from us**:
TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world.At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.#LI-EW1

The 5 basic principles of **employeneurship**
- A long-term working relationship
- Enjoy the security of a long-term contract and a stable source of income while getting the opportunity to work at diverse projects.
- Individual profit sharing
- Full transparency. That’s it. For each of your projects, you know your hourly rate, your costs, and your individual performance-based profit sharing, all in order to stimulate your inner entrepreneur.
- Business cells
- Our employeneurs are grouped in business cells based on their technical expertise. They are small, focused and function as high-grade knowledge networks. And as buzzing communities of close colleagues.
- YOUniversity
- Every employeneur drives their own career. Together, we make a plan for personal and professional growth. Receive personal coaching and an extensive training budget to keep developing yourself and deliver outperformance at our clients.
- The Entrepreneurial Lab
- Work on your technical dreams in our lab. Collaborate with others in multidisciplinary teams to unlock out-of-the-box thinking and innovative ideas as well as entrepreneurial skills.


  • QA Compliance Reviewer

    il y a 20 heures


    Gent, Belgique TMC Temps plein

    Belgium Life Sciences Ghent On-site Ready to dive into Quality Assurance? Join us to get started with an exciting journey in Pharmaceuticals and Biotechnology! - About The Member Company - We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a...

  • QA Release Associate

    il y a 19 heures


    Gent, Belgique Johnson & Johnson Temps plein

    The QA Associate Release CAR-T Europe is responsible for the release of CAR-T investigational medicinal and commercial CAR-T products manufactured in the Ghent facilities. **Key Responsibilities**: - Taking responsibility as Release Responsible of both investigational medicinal and commercial CAR-T products manufactured at the Janssen/Legend Biotech...

  • QA Consultant

    il y a 19 heures


    Gent, Belgique Capgemini Temps plein

    We’re supporting one of our biggest clients in Belgium in the set-up of two brand-new manufacturing facilities for the revolutionary new CAR-T cell therapy used to treat blood cancers. Our QA team of commissioning & qualification consultants is responsible for ensuring compliance of qualification activities through review and approval of system...

  • QA Release Associate

    il y a 19 heures


    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview**: The QA Release...

  • QA Release Associate

    il y a 19 heures


    Gent, Belgique Legend Biotech US Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an...

  • QA Excellence Manager

    il y a 19 heures


    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview**: The Manager, QA...

  • QA Excellence Manager

    il y a 19 heures


    Gent, Belgique Legend Biotech US Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an...

  • Glp QA Associate

    il y a 2 semaines


    Gent, Belgique Argenx Temps plein

    To further strengthen our Quality team, we are looking for a motivated QA Associate with a quality mindset; to fulfill a temporary position of 6 months (maternity leave). This role can be filled through consultancy as well. The GLP QA Associate will play a role in further build out of R&D quality infrastructure at argenx in close collaboration with internal...


  • Gent, Belgique Argenx Temps plein

    ROLES AND RESPONSIBILITIES: - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents - Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization - Ensure quality risk management principles are...

  • QA Investigator

    il y a 19 heures


    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview**: The **QA...