About the Company
Our client, a leading biotechnology company located in Hoofddorp, is dedicated to advancing life-changing therapies and innovative solutions in the biopharmaceutical industry. With a mission to transform the lives of patients worldwide, they are at the forefront of developing breakthrough treatments in a highly regulated environment. Their dynamic and supportive culture fosters growth, collaboration, and a passion for making a difference.

About the Position
We are seeking a skilled GMP Documentation Specialist to join our client’s Quality Assurance team. In this role, you will be responsible for managing the controlled issuance and verification of batch records, logbooks, and label packages in compliance with Good Manufacturing Practices (GMP). You will play a critical role in ensuring the accuracy, completeness, and timely execution of documentation processes, supporting the company’s commitment to maintaining the highest quality standards in their operations.

Responsibilities

• Verify controlled batch documents, logbooks, and final product labels for compliance with cGMP requirements.
• Oversee the timely consumption of consumables and GMP materials, collaborating with relevant departments to ensure efficient use.
• Ensure accuracy and completeness of QA-issued documents and escalate any compliance gaps identified during the issuance process.
• Support investigations related to deviations in the documentation process and develop effective corrective action plans.
• Execute strategic initiatives to streamline and improve the controlled issuance process.
• Cross-train colleagues on documentation procedures and best practices.
• Present and explain controlled issuance operations to internal stakeholders, ensuring alignment with compliance guidelines.
• Prioritize tasks effectively to meet deadlines while maintaining high-quality standards.

Requirements

• HBO or WO level education.
• Minimum of 2 years’ experience in document management within a regulated, GMP environment.
• Advanced proficiency in English communication (both written and verbal).
• Demonstrated attention to detail and a commitment to delivering precise, high-quality work.
• Ability to communicate effectively with peers, senior colleagues, and stakeholders.
• Strong problem-solving skills, with the capacity to think critically and identify areas for process improvement.
• Positive attitude, proactive approach, and ability to work independently or as part of a team.
• Experience with implementing corrective actions and compliance initiatives is a plus.

If you are passionate about ensuring the highest standards in the biotech industry and thrive in a fast-paced, collaborative environment, we encourage you to apply!

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