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About the role
<p><span data-contrast="none">Wil je écht impact maken? Sluit je aan bij onze Talent Pool voor QA Document Control Specialist! </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335557856":16777215,"335559685":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p>
<p><span data-contrast="none">De rol van Quality Assurance Document Control Specialist omvat verantwoordelijkheden ter onderscheiding van het documentbeheerproces binnen een celtherapie-productiefaciliteit voor zowel klinische als commerciële activiteiten in een steriele GMP-omgeving. Je zorgt ervoor dat het documentbeheersysteem, de documentopslag-, bewaring, de uitgifte en reconciliatie van documenten voldoen aan alle compliance vereisten.</span></p>
<h2><strong><span data-contrast="none">Wat mag je verwachten?</span></strong></h2>
<ul>
<li><span data-contrast="auto">Je beheert de documentcontrolesystemen en -processen voor de site.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je fungeert als Document Control reviewer voor nieuwe en herziene procedures en documenten om naleving van globale en lokale procedures te garanderen.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je ondersteunt gebruikers van het Document Management Systeem bij workflows en gebruik van het elektronische systeem.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je beheert het periodieke reviewproces voor procedures.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je staat in voor de uitgifte van batchgerelateerde documentatie ter ondersteuning van GMP‑productie.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je reconcilieert GMP‑documentatie volgens de vereisten van de document lifecycle.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je maakt en geeft GMP‑logboeken uit.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je bent verantwoordelijk voor opslag en archivering van GMP‑documenten en batchrecords.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je voert taken uit in lijn met veiligheidsbeleid, kwaliteitssystemen en cGMP‑vereisten.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je beoordeelt en keurt SOP’s en andere documentatie goed.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je stimuleert continuous improvement.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Je beschikt over geavanceerde computervaardigheden om de productiviteit van het team te verhogen en je technische en wetenschappelijke kennis uit te breiden.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
</ul>
<h2><strong><span data-contrast="none">Naar wie zijn we op zoek?</span></strong></h2>
<h3><strong><span data-contrast="none">Opleiding </span></strong></h3>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Je bent een bachelorstudent, hebt een secundair diploma of beschikt over gelijkwaardige ervaring.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":720,"335559737":0,"335559738":240,"335559739":240,"335559740":240,"335559991":360}"> </span></li>
</ul>
<h3><strong><span data-contrast="none">Ervaring</span></strong><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></h3>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Niet vereist.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Ervaring in een GMP-omgeving is een plus, geen must.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
</ul>
<h3><strong><span data-contrast="none">Talen</span></strong><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></h3>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Nederlands en technisch Engels</span><span data-contrast="none">.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
</ul>
<h3><strong><span data-contrast="none">Sterktes</span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":240,"335559739":240,"335559740":240}"> </span></h3>
<ul>
<li><span data-contrast="none">Sterke schriftelijke en mondelinge communicatieskills</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Sterke analytische vaardigheden, probleemoplossend vermogen en vaardigheden in conflicbemiddeling</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Zeer goed georganiseerd, detailgericht en in staat om meerdere taken tegelijk te beheren.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Vermogen om prioriteiten aan te passen en deadlines te halen in een snel veranderende omgeving.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Flexibel en gemotiveerd, inclusief flexibibiliteit in werkroosters.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Sterke interpersoonlijke vaardigheden en vlot communiceren op alle niveaus binnen de organisatie.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Vermogen om zelfstandig te werken met een hoge mate van verantwoordelijkheid.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
</ul>
<h3><strong><span data-contrast="none">Expertise</span></strong><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></h3>
<ul>
<li><span data-contrast="none">Kennis van GxP-kwalieitsystemen, inclusief relevante regelgeving en richtlijnen (zoals 21 CFR, ICH Q10, EU GDP/GMP, Part 11 / Annex 11, PIC/S, MHRA).</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Operationele ervaring met elektronische kwaliteitsystemen.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Ervaring met Document Management Systems (bv. TruVault, Veeva).</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
<li><span data-contrast="none">Goede kennis van Microsoft Office (Outlook, Excel, Word, PowerPoint).</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></li>
</ul>
<h2><span data-contrast="none"> </span><strong><span data-contrast="none">Wat wij jou bieden?</span></strong><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":259}"> </span></h2>
<ul>
<li><span data-contrast="none">Een </span><strong><span data-contrast="none">betekenisvolle job</span></strong><span data-contrast="none"> met een </span><strong><span data-contrast="none">uitstekende work-lifebalance</span></strong><span data-contrast="none">. Je werkt 4 dagen. Daarna geniet je van 4 dagen vrij.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li>
<li><span data-contrast="none">Een </span><strong><span data-contrast="none">ondersteunende en innovatieve werkomgeving. </span></strong><span data-contrast="none">Wij waarderen en moedigen leren en persoonlijke ontwikkeling aan. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li>
<li><span data-contrast="none">De kans om </span><strong><span data-contrast="none">samen te werken met mensen van over de hele wereld</span></strong><span data-contrast="none">.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li>
<li><span data-contrast="none">Een contract van onbepaalde duur en </span><strong><span data-contrast="none">een aantrekkelijk salarispakket</span></strong><span data-contrast="none"> aangevuld met heel wat extralegale voordelen, zoals extra wettelijke vakantiedagen, maaltijdcheques, groeps- en hospitalisatieverzekering, dubbel vakantiegeld, een eindejaars- en prestatiebonus.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li>
<li><span data-contrast="none">Veel </span><strong><span data-contrast="none">leuke en informele evenementen</span></strong><span data-contrast="none">. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li>
</ul>
<h2><strong><span data-contrast="none">Over Legend Biotech </span></strong></h2>
<p><span data-contrast="none">Legend Biotech is een wereldwijd biotechnologiebedrijf dat zicht toelegt op het ontwikkelen, produceren en commercialiseren van innovatieve en levensreddende celtherapieën, waaronder behandelingen voor hardnekkige ziekten zoals kanker. </span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></p>
<p><span data-contrast="none">Sinds onze oprichting in 2014 in Somerset, New Jersey, zijn we uitgegroeid tot een bedrijf met meer dan 2400 medewerkers in zes productie-eenheden wereldwijd. </span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></p>
<p><span data-contrast="none">In Gent richten we ons op de productie van onze geavanceerde CAR-T-therapie voor de behandeling van multipel myeloom, in samenwerking met Johnson & Johnson</span><span data-contrast="none">. </span> </p><div class="content-conclusion"><p> </p>
<p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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.</span></p>
<p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Legend Biotech maintains a drug-free workplace.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">For information related to our privacy notice, please review: <a href="https://legendbiotech.eu/en/privacy/" target="_blank">Legend Biotech Privacy Notice</a>.</span></p></div>
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