QA Release Specialist

Ghent1w ago

About the role

To support the growth of our QA Release team in Ghent, we are looking for a QA Release Specialist who will provide quality oversight for the manufacturing of our personalized CAR-T cell therapies. <h1>What can you expect? </h1> As a QA Release Specialist, you play a key role in ensuring that our CAR-T cell therapy meets the highest quality and compliance standards before (technical) release. You are responsible for reviewing and approving batch records and supporting documentation, ensuring that all manufacturing activities are performed in accordance with GMP requirements. You are responsible for;    <ul> <li>Batch Record Review & Quality Assessment: You review and approve manufacturing batch records and supporting documentation to ensure compliance with GMP and GDP standards. You assess deviations, perform risk analyses and initiate non-conformances when needed. You actively follow up with stakeholders to resolve discrepancies in a proactive manner. </li> <li>Technical Release Activities: You take quality decisions SAP S/4, ensuring batches are ready for final release. </li> <li>Compliance & Documentation: You ensure all activities are executed in line with our quality systems, safety policies and GMP regulations. You maintain accurate and complete documentation and support audit and inspection readiness. </li> <li>Stakeholder Management & Communication: You collaborate closely with Operations and other stakeholders to ensure timely and compliant batch disposition. You proactively reach out to gather missing information and ensure clear and smooth communication. </li> <li>Deviation Management & Continuous Improvement: You initiate non-conformances when needed and contribute to corrective and preventive actions. You support continuous improvement initiatives for batch record review processes and turnaround times. </li> </ul> <h1>Who are we looking for?  </h1> <h2>Education </h2> <ul> <li>A minimum of a bachelor's degree in Life Sciences or equivalent relevant experience in the pharmaceutical or biotech industry. </li> </ul> <h2>Experience </h2> <ul> <li>Preferably at least one year of relevant experience in an aseptic manufacturing environment within pharma or biotech. </li> <li>Experience in a GMP and/or QA environment is a strong asset but not required. </li> </ul> <h2>Languages </h2> <ul> <li>Fluent English (written and spoken) is required. </li> <li>Knowledge of Dutch is an asset. </li> </ul> <h2>Strengths </h2> <ul> <li>You pay attention to detail but are able to balance accuracy and efficiency. </li> <li>You thrive in a hands-on, well-structured environment, closely following procedures and guidelines. </li> <li>You are able to perform under tight deadlines and can set clear priorities. </li> <li>You are a proactive and collaborative teamplayer with great communication skills. </li> </ul> <h2> What do we offer you?  </h2> <ul> <li>A meaningful job with an excellent work-life balance. This position can either fall into our 4/4 shift regime (4 days on shift, 4 days off shift, 35h/week) or in a standard Monday to Friday daytime schedule (40h/week) depending on operational needs. </li> <li>A supportive and innovative work environment. We value and encourage learning and personal development.  </li> <li>The opportunity to work with people from all over the world. </li> <li>A permanent contract of indefinite duration and an attractive salary package complemented by a wide range of fringe benefits, including additional statutory holidays, meal vouchers, company laptop, net allowance, group and hospitalization insurance, double holiday pay, end-of-year bonus, performance bonus and the possibility to participate in our bicycle lease plan.</li> <li>Many fun and informal events. </li> </ul> <h1>About Legend Biotech </h1> Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.  The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).  In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.   <div class="content-conclusion">  Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug-free workplace. For information related to our privacy notice, please review: <a href="https://legendbiotech.eu/en/privacy/" target="_blank">Legend Biotech Privacy Notice</a>.</div>

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