Quality Assurance Document Control Specialist
- Ghent
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.
- System support and management: You will increase user engagement with our Document Management System by providing the necessary support and guidance. You manage workflow processes efficiently so that each team member can apply them quickly and easily
- 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.
- Strenghts: 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.
- Expertise: You can work smoothly with Microsoft Office applications, such as Outlook, Excel, Word and PowerPoint.
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 lot of fun and informal events.
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.
Apply now and join us in our mission to transform the world of oncology and medicine, one patient at a time.
Want some additional information?
Don't hesitate to contact Annelies!
Annelies De Coninck
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