- 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.
- 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.
- Project Coordination: Lead and coordinate projects aimed at improving documentation processes, ensuring seamless integration with existing workflows.
- 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.
- Coordinate the reconciliation and archiving of critical GMP documents, ensuring accuracy and compliance with regulatory standards.
- Manage the lifecycle of GMP documents, overseeing their creation, updates, and archival processes.
- Collaborate with teams to ensure the accurate and comprehensive creation of GMP-related documents.
- Establish and maintain a systematic process for document reconciliation and archival activities.
- Train and guide staff in adherence to GMP document reconciliation procedures.
- Identify opportunities for process enhancement and propose effective solutions.
- Participate in Digital Innovation in related activities.
- Bachelor's degree.
- Previous experience in GMP-related document management within a regulated environment.
- Fluency in French and a good level of English required.
- Proficiency in GMP standards and regulations, with a keen eye for detail and accuracy.
- Strong organizational skills and the ability to manage document lifecycles effectively.
- Familiarity with document management tools and systems specific to GMP documentation.
- Excellent communication skills and the ability to collaborate across teams.
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Documentation Coordinator - Braine-l'Alleud, België - UCB
Beschrijving
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 Coordinator .
In cooperation with Braine Technical Operations (BTO) and related supporting services, the main responsibilities of the position of Documentation Coordinator are:
Additional responsibilities:
Interested? For this position, you'll need the following education, experience, and skills:
#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