Document Control Specialist - Quality Assurance - Start People Inhouse Legend Biotech
  • Other
description du poste

table cellspacing="0" cellpadding="0" no-style="height:100%;width:100%;border-collapse:collapse;" trtd no-style="font-weight:bold;" colspan="2"Description /td /trtrtd colspan="2"pWe are seeking a dedicated Document Control Specialist to enhance and streamline document management practices at our cell therapy manufacturing facility. This role supports both clinical and commercial operations within a sterile, GMP-compliant environment. The position is vital in ensuring compliance through the proper handling, storage, issuance, retention, and reconciliation of critical documentation. /p pKey Responsibilities: /p ul liOversee, maintain, and continuously optimize document control systems and processes for the facility. /li liReview newly created and revised procedures to ensure they align with both local and global standards. /li liOffer guidance to users regarding document workflows and electronic document management systems. /li liManage the scheduled review process for procedures. /li liIssue batch-related documentation in support of GMP manufacturing activities. /li liReconcile GMP documents according to lifecycle requirements. /li liPrepare and distribute GMP logbooks. /li liSupervise the storage, retention, and archiving of GMP records and batch documentation. /li liEnsure all tasks are performed in compliance with safety protocols, quality systems, and current GMP regulations. /li liReview and approve SOPs and other controlled documents. /li liLead continuous improvement initiatives within the document management process. /li liUtilize advanced computer skills to enhance efficiency and support technical/scientific capabilities. /li /ul /td /tr trtd no-style="font-weight:bold;" colspan="2"Company /td /trtrtd colspan="2"pOur client, a biotech company located in Zwijnaarde, is a global biotechnology firm bringing innovative CAR-T cell therapy to Ghent. The company makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases. They are currently experiencing significant growth and are seeking motivated and dedicated team members. /p /td /tr trtd no-style="font-weight:bold;" colspan="2"Profile /td /trtrtd colspan="2"p We are looking for you in case you have:  /p ul li Nice experience within administration, where you are used to handling complex tasks. /li li Excellent written and verbal communication skills in Engllish. /li li Analytical problem-solving, and conflict resolution abilities. /li li Highly organized, motivated, and capable of multitasking with attention to detail. /li li Ability to adapt to shifting priorities and meet critical deadlines in a dynamic and fast-paced environment. /li li Effective interpersonal skills for communication across organizational levels. /li li Ability to work independently with strong accountability. /li li Proficient in Microsoft Office applications (Outlook, Excel, Word, PowerPoint). /li li Familiarity with Document Management Systems (TruVault/Veeva) is preferred. /li /ul /td /tr trtd no-style="font-weight:bold;" colspan="2"Offer /td /trtrtd colspan="2"p bWhat We Offer: /b /p ul li A rewarding position with excellent work-life balance; work 4 days per week (10 hours/day). /li li A supportive and innovative work environment that fosters learning and personal growth. /li li Opportunities to collaborate with colleagues from diverse backgrounds. /li li Initial engagement through interim contracts, transitioning to a permanent contract after six months. /li li Competitive salary package with numerous benefits, including extra statutory vacations, meal vouchers of €7/day, group and hospitalization insurance upon permanent contract, double vacation pay, and performance bonuses. /li /ul /td /tr /table

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