QA Document Control Specialist

il y a 3 jours

Gent, Belgique Legend Biotech EU Young Graduates Temps plein

As a Quality Assurance Document Control Specialist, you are a cornerstone in our mission to save lives. Together with your colleagues from the Document Control Team, you monitor the integrity of our documents. You manage the document lifecycle, from creation to archiving, ensuring quality and compliance.

**What can you expect?**

In our GMP-controlled environment, your expertise ensures the highest quality of cell therapy products. Your tasks and responsibilities include, but are not limited to:

- **Document management**:You manage our document control systems, ensuring every process aligns seamlessly with our operational needs. Your oversight guarantees the smooth management of vital documentation throughout the site.
- **Review and compliance**: You review new and revised procedures and documents to ensure they meet stringent global and site-specific standards. Your keen eye for detail ensures every document reflects our commitment to quality and compliance.
- **Documentation issuance**: You oversee the issuance of batch-related documentation, a cornerstone of our GMP manufacturing process. Your role is to ensure that every batch produced meets our high standards and regulatory requirements.
- **Document lifecycle management**: You handle the reconciliation and archiving of GMP documentation, maintaining a meticulous record of our manufacturing journey. Your attention to detail ensures the integrity and accessibility of vital records for both current operations and future audits.

We work in a **shift regime, no nights but weekends**.

**Who are we looking for?**

We are looking for people who thrive in a GMP-regulated environment, and who are passionate about quality.
- **Education**: You have a secondary school or bachelor's degree.
- **Experience**: We offer extensive, in-house training after which you can start working smoothly in your new role.
- **Languages**: You are **proficient in Dutch and/or English, with strong written and oral communication skills**.
- **Strengths**:You have a **strong sense of responsibility, and you are highly motivated and well-organized, capable of multitasking**. You are a real team player, but you can also work well independently. You have a positive and problem-solving mindset and an eye for detail.

**What do we offer?**
- A **meaningful job**, **close to your home**, with a very nice **work-life balance**. **You work 4 days, then you have 4 days off**.
- At Legend Biotech, you find more than a career. We offer you a **path to growth, learning and personal development **in a **warm, supportive and innovative work environment, **surrounded by colleagues you can really count on.
- Enjoy the opportunity to **work with people from all over the globe. **We are fully committed to diversity and inclusion and value every voice.
- The **opportunity to volunteer for numerous projects and charities**, allowing you to develop new skills.
- An **indefinite contract and an attractive salary complemented by a comprehensive package of fringe benefits **such as additional legal vacation days, meal vouchers, group and hospitalization insurance. And as icing on the cake, you'll also receive annually double vacation pay, an end of year bonus and a performance bonus.
- A l**ot of fun** and informal events.

LI-AG1

**About Legend Biotech**
Legend Biotech is a global biotechnology company developing, manufacturing, and commercializing innovative and life-saving cell therapies in the fight against diseases that are considered intractable and incurable, including cancer.

Since our establishment in 2014 in Somerset, New Jersey, we have grown into a company of more than 1,800 employees spread across six manufacturing units worldwide. Two of these are in Ghent: Obelisc (Technologie Park, Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde)

In Ghent, Legend Biotech focuses on producing its advanced CAR-T therapy for the treatment of multiple myeloma, a common but difficult-to-treat blood cancer, and on bringing this live-saving therapy to patients in Europe and far beyond.

Creating hope and new opportunities for patients and contributing to a future where all cancers are curable is what everyone drives here at Legend Biotech, regardless of their role or function.

  • QA Specialist

    il y a 1 semaine

    Gent, Belgique MindCapture Temps plein

    QA SPECIALIST - Biotech- GhentWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success. We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on...

  • QA Document Control Specialist

    il y a 2 semaines

    Gent, Flandre, Belgique Legend Biotech EU Young Graduates Temps plein

    As a Quality Assurance Document Control Specialist, you are a cornerstone in our mission to save lives. Together with your colleagues from the Document Control Team, you monitor the integrity of our documents. You manage the document lifecycle, from creation to archiving, ensuring quality and compliance.What can you expect?In our GMP-controlled environment,...

  • QA Release Specialist

    il y a 2 semaines

    Gent, Flandre, Belgique MindCapture Temps plein

    QA RELEASE SPECIALIST Biotech GentWHAT IS OFFEREDBe part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.ABOUT THE COMPANYMindCapture supports in the recruitment of this...

  • QA Specialist

    il y a 2 semaines

    Gent, Flandre, Belgique Nuwhï Temps plein

    About the role of QA SpecialistDepending on your level of experience, you collaborate on or lead the management of projects or operational services linked to quality assurance system of various clients (pharma, biotech, medtech), such as:Deviations, CAPA, Change Control, OOS management; Supplier/Vendor management; PQR writing/reviewing; Audit management;...

  • QA CSV Systems Associate

    il y a 2 semaines

    Gent, Flandre, Belgique Perrigo Temps plein

    Description OverviewPerrigo is a prominent global supplier of over-the-counter (OTC) health products and wellness solutions aimed at improving individual well-being.Originally Omega Pharma, the European branch now operates in 30 countries with strong local ties. You may recognize us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin,...

  • QA Release Supervisor

    il y a 3 semaines

    Gent, Belgique MindCapture Temps plein

    QA RELEASE SUPERVISOR - Biotechnology- GhentABOUT THE COMPANY The **QA Release Supervisor** holds a pivotal role, ensuring the quality oversight of personalized cell therapy production for both clinical and commercial requirements within a sterile GMP environment. This position involves supervising QA release associates, collaborating with manufacturing to...

  • QA Consultant

    il y a 2 semaines

    Gent, Flandre, 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 qualification...

  • QA Consultant

    il y a 2 semaines

    Gent, Flandre, 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 qualification...

  • QA Release Supervisor

    il y a 2 semaines

    Gent, Flandre, Belgique MindCapture Temps plein

    QA RELEASE SUPERVISOR Biotechnology GhentABOUT THE COMPANYThe QA Release Supervisor holds a pivotal role, ensuring the quality oversight of personalized cell therapy production for both clinical and commercial requirements within a sterile GMP environment. This position involves supervising QA release associates, collaborating with manufacturing to...

  • QA Consultant

    il y a 3 semaines

    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 Car-t Qualification Lead Emea

    il y a 1 mois

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe. **CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T-cells and are engineered to...

  • QA Consultant

    il y a 4 semaines

    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 Consultant

    Il y a 2 mois

    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 Supervisor Qpip

    il y a 7 jours

    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 Supervisor...

  • QA Car-t Qualification Lead Emea

    Il y a 3 mois

    Gent, Belgique Johnson & Johnson Temps plein

    **CAR-T QA C&Q Engineer** The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a CAR-T QA C&Q Engineer for the CAR-T hub in Europe. **CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system....

  • QA Car-t Qualification Lead Emea

    il y a 2 semaines

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T-cells and are engineered to eliminate...

  • Sr. QA Associate Car-t Emea

    il y a 3 semaines

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Senior QA Associate for the CAR-T hub in Europe. The position will be based in Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and...

  • QA Lead Investigations

    il y a 2 semaines

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a QA Operations Lead Investigations, for the CAR-T hub in Europe. The position will be based in Ghent, Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate...

  • QA Car-t Qualification Lead Emea

    il y a 2 semaines

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    CAR-T QA C&Q EngineerThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a CAR-T QA C&Q Engineer for the CAR-T hub in Europe.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are...

  • Senior Manager QA Operations

    il y a 3 semaines

    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 **Senior**...