Documentation Specialist, Hoofddorp, Noord-Holland

The Company 
Our client is a biopharmaceutical company focused on developing innovative cancer treatments using advanced cell therapies to harness the immune system, aiming to improve patient outcomes.

The Role 
This role is centered around managing and verifying documentation in a regulated environment, ensuring strict adherence to Good Manufacturing Practices (GMP). You will play a crucial role in supporting quality assurance efforts by identifying compliance issues and implementing corrective actions when deviations are detected in the documentation process.

Responsibilities

- Ensuring accuracy and compliance of controlled batch documents, label packages, and logbooks with cGMP standards.
- Managing the issuance and tracking of controlled documents, ensuring completeness and proper handling.
- Identifying and escalating any compliance gaps in the controlled issuance process. 
- Supporting strategic initiatives to enhance the documentation process and ensure efficiency.
- Investigating deviations in the documentation process and developing corrective action plans to address them.
- Assisting with both internal and external audits by providing relevant documentation and ensuring regulatory compliance.
- Managing the timely consumption and reporting of consumables and GMP materials. 
-Training colleagues and other internal stakeholders on document issuance requirements and guidelines.
-Effectively communicating with peers, stakeholders, and senior management regarding documentation and compliance issues. 

Requirements 

• 2+ years of experience in document management within a regulated environment (such as pharmaceuticals, biotechnology, or similar industries) and advanced knowledge of Good Manufacturing Practices (GMP).
• Advanced proficiency in English, both written and verbal, with the ability to clearly explain documentation processes and requirements to different internal audiences.
• Demonstrated ability to deliver accurate and thorough work with high attention to detail in routine tasks, while identifying compliance gaps and developing corrective action plans.
• Proven ability to prioritize tasks, manage deadlines, and handle multiple responsibilities efficiently
• Ability to communicate effectively with peers, senior colleagues, and stakeholders, cross-train team members, support internal and external audits, and be available to work during peak periods (e.g., summer and December holidays) and weekends.

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