Pauwels Consulting
EN
CAR-T Operations Batch Record Reviewer II
Pharma & Sciences - Quality & Compliance - zwijnaarde
Based in Ghent, Belgium, you will join a collaborative team, full of passionate change-makers. You will be a key member of an international and dynamic team in a fast-growing & innovative organisation, inspired by break-through therapies in immune-oncology field

Position overview

The Operations Batch Record Reviewer is an exempt level position working within Technical Operations team, responsible for the batch record review of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule. The Batch Record Reviewer will work in a detail-oriented compliant manner

  • Perform First Quality Review within Operations for Executed Batch Records Daily:
  • Assist in the Correction of Deficiencies Found within the Documentation Reviewed per the cGMPs and SOPs on a Daily Basis:
  • Ensure Documents Like Batch Records, Labels, Forms, etc. are Printed and Available for Production:
  • Check Completeness of All Associated Documentation Ensuring Compliance with Written Policies and Procedures as Required for Batch Release:
  • Communicate Effectively with Other Departments within the Organization and Function within a Team Environment:
  • Navigate through Various Online Platforms, Including MES, SAP, COMET, and eLIMS:
  • Facilitate and Coordinate with Project Teams to Enhance, Improve, and Streamline Batch Records Cycle Time
Reference number: 71484

What are we looking for?

  • Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
  • Must possess good written and oral communication skills. Must be proficient in MS Office Suite and be able to coordinate multiple tasks efficiently. Must be willing to learn and be proficient in eLIMs, S4HANA (SAP) , MES (Manufacturing Electronic Batch Record), and a Learning Management System. Good interpersonal skills and the ability to work well in a team environment is a must
  • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
  • Good developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment,.
  • Strong analytical, problem solving, pragmatic and positive critical thinking skills
  • Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
  • Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures
  • Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
  • Proficiency with MES/EBR is a nice to have
  • Ability to accommodate shift work including evenings and weekends as required by the process.
  • Ability to accommodate unplanned overtime on little to no prior notice
  • Dutch and English

What do we offer?

  • Uitdagende projecten in lijn met jouw interesses en talenten
  • Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
  • Mogelijkheid tot het volgen van extra opleidingen
  • Inspirerende netwerkevents en legendarische afterwork drinks
  • Sterk netwerk van toonaangevende klanten
  • Expertise binnen IT, Engineering en Life Sciences
  • Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors
  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
  • Un package salarial attractif avec de nombreux avantages extra-légaux
  • Un suivi clair et personnalisé, une communication transparente autant durant la période de recrutement qu’une fois l’entrée effective en poste
  • La possibilité de suivre des formations
  • Divers événement vous permettant de développer votre réseau et des afterwork drinks légendaires
  • Un réseau puissant de clients, leaders dans leur domaine
  • Une expertise dans les domaines de l’informatique, de l’ingénierie et des sciences de la vie
  • Un tremplin vers une évolution rapide pour les juniors et la possibilité de partager des connaissances acquises pour nos employés plus seniors
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Julie Bataille https://a.storyblok.com/f/256509/2333x3500/b71c31b409/julie-bataille.png/m/360x0/filters:format(webp)
Julie Bataille
Account Manager Life Sciences
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