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.
For our Quality Team, we are looking for a Quality Validation Specialist.
You will be responsible for Change Control System, be part of site projects and multi-disciplinary teams, Quality approver of project and Validation documentation. The position is based in Porriño, Spain (situated 20min from Vigo).
Key responsibilities:
Approval as Quality of documentation (e.g. URS, Equipment Qualification protocols, Process Validation protocols, Cleaning Validation protocols, SOPs, forms).
Quality oversight of Qualification and Validation, Engineering and Maintenance activities.
Data integrity risk assessments approval.
Computer System Validation approval.
Ensures the compliance of the local qualification activities with Lonza Corporate requirements and standards and current regulatory requirements.
Develops and implement continuous improvement actions looking for a more efficient process, following the Operational Excellence strategy.
Perform the required quality metrics or provide the corresponding raw data (KPIs, PQR, Q council, etc).
Actively participation in multidisciplinary teams as required.
SME in audits, customer inspections and/or regulatory agencies.
Key requirements:
Preferably Engineering Degree (Chemical, Mechanical or Automation) or Bachelor of Science (Chemistry, Biochemistry, Pharmacy).
English Business Fluent.
Familiarity with biologics manufacturing processes and technical issues is strongly desired.
Technical background in Engineering projects and Validation is strongly desired.
Ability to execute and plan the routine tasks.
Team player who can operate independently.
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.
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