Are you detail-oriented and passionate about quality documentation within a GMP environment? As a Quality Assurance Document Control Specialist at a leading Biopharma cell therapy manufacturer, you will play a critical role in ensuring document compliance across clinical and commercial manufacturing operations.
This role offers exposure to electronic quality systems, batch documentation, SOP management, and archival processes within a sterile GMP environment. It is an excellent opportunity for candidates starting or developing their career in Quality Assurance within the biopharmaceutical industry.
Must Have Requirements
* Undergraduate, secondary degree, or equivalent professional experience
* Knowledge of GxP regulations (EU GMP/GDP, 21 CFR, ICH Q10, Annex 11 / Part 11, PIC/S, MHRA)
* Operational experience with electronic quality systems
* Experience with document control or document management processes
* Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint
* Fluency in Dutch and technical English
* Ability to work in compliance with cGMP and quality system requirements
Desirable Requirements
* Experience working in a GMP manufacturing environment
* Experience with Document Management Systems such as Veeva or TruVault
* Experience with batch documentation issuance and reconciliation
* Experience with SOP review and approval workflows
* Experience in biopharmaceutical, biotech, or cell therapy manufacturing environments
* Experience supporting clinical and/or commercial manufacturing operations
Responsibilities
* Manage site document control systems and processes
* Review and approve SOPs and controlled documents
* Support document management system users and workflows
* Manage periodic review of GMP documentation
* Issue and reconcile batch-related documentation
* Create and issue GMP logbooks
* Ensure storage, archival, and retention of GMP records
* Reconcile documentation in line with document lifecycle requirements
* Support continuous improvement initiatives
* Ensure compliance with safety policies, quality systems, and cGMP standards
What We Offer
* Meaningful QA role within advanced cell therapy manufacturing
* 4 days on-site followed by 4 days remote work pattern
* Supportive and innovative working environment
* Exposure to international and multicultural teams
* Interim contract with permanent opportunity after 6 months
* Attractive salary package with benefits including meal vouchers, insurance, bonuses, and additional vacation days
Interested in Learning More?
If you would like to explore this opportunity confidentially, feel free to contact:
Maurits van Sloun
📧 m.vansloun@panda-int.com