GMP Documentation Manager
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are currently looking for a GMP Documentation Manager to join our MSAT department. This function oversees several GMP Documentation Specialists within MSAT team and ensures the timely completion of deliverables of the team. This function provides guidance to the team members and ensures the team performs at expected level and ensures proper interaction between the team with other internal and external parties.
- Creation of GMP and process related documents such as BRMs, protocols and reports as per agreed timeline and per house procedure.
- Full adherence to the house procedures in his area of supervision
- Ensures team members are competent for the assigned responsibilities by providing adequate coaching, monitoring their performance and developing appropriate IDP
- Successful management of change controls and deviations that are owned by MSAT department as per agreed timeline
- Proper system implementation and associated training within the department
- transparent and timely communication to the MSAT head on the issues and actively participates in resolving the issues
- Ensures full adherence to the house procedures for all activities performed under his/her supervision
- Strongly collaborates with MSAT head on achieving the departmental goals
- Ensures budgets, schedules, and performance requirements are met in her/his area of supervision
- Solid knowledge in drafting documentation for cell-based processes, aseptic manufacturing and GMP regulation
- Advanced supervisory tasks and involvement in recruitment, selection, coaching and training of MSAT staff.
- This function must perform independently in her/his area of responsibility and is responsible for ensuring in time delivery of his/her area of supervision.
- Good knowledge on systems applicable for drafting documents for manufacturing in GMP environment
- Experience in working in a fast pace environment and demonstrating professional response to unexpected events.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.