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
As a Quality Documentation Specialist is responsible for verifying controlled batch documents, labels, and logbooks in compliance with cGMP. The role ensures accuracy and completeness of QA documents, identifies compliance gaps, and supports process improvements and deviation investigations.

Responsibilities
– Verify controlled batch documents, labels, and logbooks.
– Ensure timely consumption or reporting of consumables/GMP materials.
– Maintain accuracy and completeness of QA documents.
– Identify and escalate compliance gaps.
– Support process improvements and corrective actions for controlled issuance.
Additional duties as assigned.

Requirements
– Education: HBO or WO level.
– Experience: 2+ years in document management within a regulated environment.
– Language: Advanced English communication.
– Skills: Attention to detail, ability to prioritize, and effective communication with peers and stakeholders.
– Knowledge: Advanced technical knowledge of GMP, with the ability to cross-train others and explain document issuance processes clearly.

Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
 

53877