GMP Systems Technician
Today, Lonza is a global leader in life sciences operating across three continents. 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 an experienced GMP Systems Technician to join our site in Porrino in North West Spain.
The Quality Systems Technician is accountable for standardization of global and locales procedures affected by CFR 21 Part 11 & Data Integrity in OT Departments. Technical support for the qualification of OT systems. SME in Data Integrity and CFR 21 Part 11 for OT systems.
- Standardization between global and locales procedures affected by CFR 21 Part 11 & Data Integrity in OT Departments.
- Definition of Standards for Data Integrity Periodic review of validated OT systems: (Audit Trail, Authorizations and Permissions, Backup copies etc.)
- Evaluation and collaboration to compliance with the CFR 21 Part 11 & Data Integrity rules in OT systems
- Standardization and maintenance of User management (privileges/access) in OT Systems
- SME Data Integrity and CFR 21 Part 11 for OT systems
- Final review/approve of OT GMP documents
- Technical support for the qualification of OT systems with associated software and validation of OT : implementation and maintenance, as well as updates (upgrades)
- Follow-up of the applicable procedures in the execution or support of validation activities (Test Scripts execution, etc.)
- In new Projects : Collaboration and review of the applicable procedures related wit OT Systems
- Collaborate with validation department in test and document definition before the validation of a OT system
- Collaborate and review CRs and CAPAS associated with OT systems.
- Acts as a member in QC-IT projects, e.g. up-grades of software systems, is seen as an interface between IT dept. and QC
What we need you to have:
- Life Sciences degree qualified, ideally within Pharmacy, Engineering, Chemistry or Administration.
- Hands one experience within a GMP environment and QC Systems and IT.
- Supports a culture of process improvement and problem solving.
- Strong office software experience (Word, Excel, PowerPoint) and Documentum
- Fluency in Spanish and English.
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.