The Company:
Our client is a leading biopharmaceutical company renowned for its groundbreaking work in innovative immunotherapies, especially in the realm of cancer treatment. By leveraging the power of the immune system, they aim to transform patient outcomes. With a passionate team of experts and scientists, the company is dedicated to pushing the limits of medical advancements and creating life-changing treatments.

Role Description:
The Documentation Specialist will play a vital role in supporting and verifying controlled documentation within a regulated environment. This position involves ensuring the accuracy, compliance, and timely processing of controlled issued batch documents, label packages, and logbooks, as well as overseeing the consumption of GMP materials.
 
 
Responsibilities:
-Verify controlled issued batch documents and label packages, including Final product labels, per cGMP standards, as required by operational departments.
-Ensure verification of controlled issued logbooks.
-Oversee timely consumption of consumables/GMP materials, or inform the designated responsible person as needed.
-Ensure accuracy and completeness of QA-issued documents.
-Identify and escalate compliance gaps across the controlled issuance process.
-Execute strategic initiatives to improve the controlled issuance process.
-Support or investigate deviations in the controlled issuance process and develop corrective action plans.
-Perform additional duties as assigned.
-Delegate responsibilities to qualified deputies as necessary.
 
Requirements:
– HBO or WO level education, with 2+ years of experience in document management within a regulated environment.
-Advanced technical knowledge in Good Manufacturing Practices (GMP).
– Proficiency in English and an ability to effectively communicate with peers, senior colleagues, and other stakeholders.
-Demonstrated ability to prioritize tasks, meet deadlines, and ensure the accuracy of routine document-related tasks.
 
Other Information:
This is a full-time role offering the chance to work in a dynamic and innovative environment where precision and technology drive continuous improvement.
 

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