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Manufacturing Quality Specialist
hace 4 meses
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 Manufacturing Quality Specialist.
You will be responsible for provide Quality support to Manufacturing operations and to ensure compliance with quality standards during operations. Alternatively, representing Manufacturing Quality in multi-disciplinary teams required by deviations or projects. The position is based in Porriño, Spain (situated 20min from Vigo).
Key responsibilities:
Fully support to Manufacturing operations 24h/day on call.
Ensure quality standards during operations.
Manages the following Quality systems as per the standard procedures: Deviations, Investigations, Change Request and CAPAs.
Lead the Deviation Review Board (DRB) and Change Review Board (CRB) as applicable.
Review and approval of master documentation (e.g. SOPs) needed for operations.
Performs the cell banks release and pre-shipment acceptance
Perform the required quality metrics (KPIs, QMR, etc)
Actively participation in multidisciplinary teams required by deviations or global Quality.
SME in audits, customer inspections and/or regulatory agencies.
List key requirements here.
Bachelor of Science or Associate Degree of Microbiology, Biochemistry or equivalent Science.
English Business Fluent.
Familiarity with biologics manufacturing processes and technical issues is strongly.
Availability for rotational on call shifts.
Ability to provide a robust and agile Quality support when a process issue happen.
Ability to execute and plan the routine tasks.
Good comunication skills.
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.
Reference: R60786