CAR-T Operations Batch Record Reviewer
Your new company
Our client, in Belgium, is a global biotechnology company dedicated to treating and curing life-threatening diseases. They develop cell therapies across a diverse range of technology platforms, including autologous and allogenic chimeric antigen receptor T – cell and NK cell – based immunotherapy. They are committed to improving the lives of patients worldwide at multiple sites and their goal is to reimagine healthcare and to deliver transformative treatments in the fields of oncology and cell therapy.
Your new role
- Checking the completeness of all associated documentation, ensuring compliance with written policies and procedures as required for batch release.
- Performing First Quality review within Operations for executed batch records daily.
- Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
- Assisting in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on a daily basis.
- Assisting in process audits and internal audits as needed.
- Working closely with QA functional teams to align and promote awareness of data integrity and good documentation practices.
- Navigating through various online platforms, including MES, SAP, COMET, and eLIMS.
- Routinely interacting with other departments to collect batch record information or work to resolve documentation issues.
What you'll need to succeed
Experience within a cGMP or ATMP environment in the biotech/biopharma industry. The ability to accommodate shift work, including weekends as required by the process. The client will offer you the necessary training to get you started in your new role.
You should have knowledge of cGMP regulations and FDA/EU guidelines and experience in Microsoft Office applications such as Outlook, Excel, Word and PowerPoint. You are fluent in Dutch or English, with strong oral and written communication skills.
You must be in the Ghent region or have affiliation with the area. Perhaps you have family there or connections from studies.
What you'll get in return
Our client in Belgium is offering contracts directly, so you will sign your contract with them. After successful interview rounds and offer acceptance, you will get a meaningful job that contributes directly to the well-being of patients with an excellent work-life balance. You’ll be part of a supportive and innovative working environment that encourages learning and personal development. Alongside that, you will get the chance to work in a multinational setting with an open – ended contract and an attractive salary package. Other secondary benefits include additional statutory vacations, meal vouchers, group and hospitalisation insurance, an end-of-year bonus and performance bonus.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
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Overzicht
- Contractvorm
- Permanent
- Branche
- Pharmaceutisch
- Locatie
- Terneuzen
- Vakgebied
- Life Sciences
- Salaris
- Attractive salary package
- Referentie:
- 1048624
Spreek met een consultant
Telefoonnummer: 0630257804
SOORTGELIJKE VACATURES CAR-T Operations Batch Record Reviewer
CAR-T Operations Supervisor
Belgium | CAR-T Operations Supervisor | cGMP | Inspections | Documentation | Batch records | 1048623 |Gent, BelgiumAttractive salary package