- You will be accountable for overseeing the management of both paper and electronic documents within the Biologics Pilot Plant and the future Gene Therapy Plant.
- As an expert, you will lead initiatives for guaranteeing and reinforcing good documentation practices.
- You will define and implement strategies for documentation management processes, ensuring compliance with regulations and internal standards.
- You will guide initiatives to improve digital strategies and implementation, including and especially serving as a power user in the Electronic Document Management System (EDMS).
- You will ensure the development and maintenance of a comprehensive training matrix and associated training plans, in collaboration with managers and aligned with updated job descriptions.
- You will maintain a list of trainers and single points of contact for all Standard Operating Procedures (SOPs), managing training, changes and updates efficiently.
- Responsible for developing and delivering GMP training content and organizing training sessions for both the Biologics Pilot Plant and the future Gene Therapy Plant.
- You will supervise the coaching strategy for the Biologicals Pilot Plants.
- You will supervise the training schedule, sessions organization, and maintenance of training records, ensuring compliance with regulatory requirements.
- You will coordinate, prepare, and manage all documentation and training aspects for audits and quality meetings, ensuring readiness and compliance.
- Define and track Quality Key Performance Indicators (KPIs) related to training, coaching, and documentation processes.
- Conduct gap/risk analysis as necessary and steer continuous improvement projects related to training, documentation, and digitalization, in alignment with UCB's overarching processes.
- Manage deviations and change controls related to training and documentation, ensuring timely resolution and compliance.
- Bachelor's degree in sciences
- Minimum 5 years' experience in a regulated pharmaceutical company
- Experience in a GMP environment
- Experience in training management and documentation management (incl. eDMS)
- Proficiency in deviation and change control management
- Strong communication and problem-solving skills
- Fluency in French and good knowledge of English, both written and spoken.
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Documentation & Training Manager - Braine L'alleud, België - UCB
Beschrijving
Make your mark for patients
We are seeking a Documentation and Training Manager who is passionate about compliance and excellence to join our team at the Biologics Pilot Plant, located on our UCB campus in Braine l'Alleud, Belgium.
About the Role
As the Documentation and Training Manager, you will play a pivotal role in ensuring the smooth operation of our Biologics Pilot Plants. You will be responsible for managing documentation and training systems, in the area of monoclonal antibodies manufacturing and Gene Therapy.
Who You'll Work With
You'll collaborate closely with cross-functional teams, including project teams, production entities, and quality assurance, to ensure alignment with regulatory standards and internal practices.
What You'll Do
Document/Data Management/Digitalization:
Knowledge, People Qualification, and Training Management:
General Quality Systems:
Interested? For this role, we're looking for the following education, experience, and skills:
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
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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