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Open nowPosted 8 days ago

QA Documentation Specialist

EURES job mobility portal39,190 open roles

Where
Groot-Amsterdam, Netherlands
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Your applicationOpen nowQA Documentation SpecialistEURES job mobility portal · Groot-Amsterdam, Netherlands
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  5. 34.1%30 days
This job: posted 8 days ago

The posting

Bewaar QA Documentation Specialist 1050519 | QA Documentation Specialist | QA | Batch Record | GMP | Documentation | Labels Quality Operations Documentation Specialist About the Company Our client is a leading biopharmaceutical organisation at the forefront of advanced cell therapy manufacturing. Operating one of Europe's most innovative production facilities in the Amsterdam region, the company is dedicated to developing and manufacturing life-changing therapies for patients with serious diseases. Working in a highly regulated GMP environment, you will be part of a collaborative and fast-paced team focused on quality, innovation, and continuous improvement. The organisation continues to invest heavily in its people, technology, and manufacturing capabilities, offering excellent opportunities for long-term career development within the rapidly growing cell and gene therapy sector. About the role As a Quality Operations Documentation Specialist, you will be responsible for the controlled issuance and verification of GMP documentation, supporting manufacturing and operational teams in maintaining full compliance with regulatory and quality standards. You will work closely with cross-functional stakeholders to ensure documentation processes are executed efficiently while driving continuous improvements across quality systems. Key responsibilities - Verify and issue controlled batch records, label packages, and final product labels in accordance with cGMP requirements. - Review and control GMP logbooks and associated documentation. - Ensure the accuracy, completeness, and compliance of QA-issued documents. - Manage the timely consumption and reconciliation of GMP materials and consumables used within documentation processes. - Identify, investigate, and escalate compliance issues related to document control activities. - Support deviation investigations and implement effective corrective and preventive actions (CAPAs). - Cont...

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