Make your mark for patients
To strengthen our QA Systems & Continuous Improvement Team, based in Braine, Belgium, we are looking for a talented individual to fill the position of: Documentation & Training Coordinator .
In cooperation with Braine Technical Operations (BTO) and related supporting services, the main responsibilities of the position of Documentation Coordinator are:
1. As a Documentation Coordinator, your primary role will involve coordinating the reconciliation and archival activities of critical GMP documents. You'll play a pivotal role in ensuring the accuracy and completeness of GMP-related documents while managing their lifecycle, from creation to archival, in compliance with regulatory standards.
2. Operational Team Management: Directly manage and provide operational leadership to a team ranging from 5 to 10 individuals involved in the reconciliation and archival of GMP documents.
3. Project Coordination: Lead and coordinate projects aimed at improving documentation processes, ensuring seamless integration with existing workflows.
4. Backup Responsibilities: Serve as the backup for the line manager, stepping in to oversee day-to-day activities (documentation, archive, training and retained sample activities) in their absence.
Additional responsibilities:
5. Coordinate the reconciliation and archiving of critical GMP documents, ensuring accuracy and compliance with regulatory standards.
6. Manage the lifecycle of GMP documents, overseeing their creation, updates, and archival processes.
7. Collaborate with teams to ensure the accurate and comprehensive creation of GMP-related documents.
8. Establish and maintain a systematic process for document reconciliation and archival activities.
9. Train and guide staff in adherence to GMP document reconciliation procedures.
10. Identify opportunities for process enhancement and propose effective solutions.
11. Participate in Digital Innovation in related activities.
Interested? For this position, you’ll need the following education, experience, and skills:
12. Bachelor’s degree.
13. Previous experience in GMP-related document management within a regulated environment.
14. Fluency in French and a good level of English required.
15. Proficiency in GMP standards and regulations, with a keen eye for detail and accuracy.
16. Strong organizational skills and the ability to manage document lifecycles effectively.
17. Familiarity with document management tools and systems specific to GMP documentation.
18. Excellent communication skills and the ability to collaborate across teams.
#S&TS
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!