Compliance Auditor De Bilt • SIRE Life Sciences

The Company
Our client is a global healthcare company focused on discovering, developing, and providing innovative medicines, vaccines, and animal health products. With a strong emphasis on research and development, it is committed to improving patient outcomes and addressing unmet medical needs across various therapeutic areas, including oncology, immunology, cardiology, and infectious diseases. 

About the Role
As a Compliance Auditor, you will help ensure that all pharmaceutical manufacturing and testing processes meet the highest standards of quality and regulatory compliance. Working within a GMP-regulated environment, you will conduct audits of procedures, equipment, systems, and documentation to verify compliance with SOPs, cGMP guidelines, and global regulatory requirements. This role is essential in supporting the release of materials and products, as well as driving continuous improvement across operations.

Responsibilities
- Conduct audits of processes, data, documentation, equipment, and systems (including computer systems) to assess compliance with SOPs, cGMP, and relevant regulations
- Review and approve production and analytical documentation for the release of APIs, clinical trial materials, and packaged products
- Identify, communicate, and resolve audit findings with relevant departments
- Support internal inspections and provide input during regulatory agency inspections
- Draft audit reports summarizing observations and ensure timely follow-up on corrective actions
- Collaborate with cross-functional teams to support continuous quality improvement
- Work under supervision or as part of a team, with increasing independence over time

Requirements
- Professional experience in the pharmaceutical, chemical, or regulatory environment (e.g., GMP manufacturing, quality, or inspection)
- Sound working knowledge of current Good Manufacturing Practices (cGMP) and regulatory standards
- Strong attention to detail and a high sense of integrity and compliance
- Effective communication skills, both written and verbal
- Proficiency in using quality systems and standard office tools (e.g., MS Office)

Other Information
The position is designed to be a long-term, permanent role.

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