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.
Lonza Porriño is an integrated global contract manufacturing organization (CMO) offering a complete range of therapeutic protein manufacturing services.
We have the ability to provide these services in a fully scalable manner and at every stage of the development process. Our capabilities include technology transfer, analytical development and testing, scale up and cGMP manufacturing and support services.
Acts as Quality Subject Matter Expert for the Quality Unit matters in different multidisciplinary customer project teams, and as a liaison among customers and other departments.
Leads, as applicable, meetings focused on quality items, product-related projects, test method transfers and validations, annual product review, continued process verification and customer related topics.
Key responsibilities :
Provide specific technical knowledge for the Quality Unit organization (participating on investigations, studies and trending evaluation as well as innovation and improvements projects).
Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner.
Perform, review, approve (as applicable) and follow up tech transfers and methods validation documentations related to the different customer s projects.
Prepare and execute specific protocol studies requested by customers and present data and reports (internally and in front of customers).
Perform the monitoring of the process from the quality perspective.
Lot Disposition for the batch release.
CPV (continued process verification) management.
APR (annual product review) management.
Creation, review and approval (as applicable) of Stability Protocols and Reports.
CCRs (Customer Change Requests) management.
Create, review and approval of product specifications for each specific customer as applicable.
Review and approve process sampling plans and process descriptions.
Product compliant approval and product recall.
Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required.
Perform other duties as assigned.
Key requirements :
Relevant University Degree in Life Sciences
Solid experience in the pharmaceutical / biotech industry in the Quality field (ideally in Quality Assurance and Quality Control), 5-10 years
Good knowledge of GMP regulations.
Business fluent Spanish and English
Strong written and oral communication skills including public speaking. Able to clearly express ideas and point of view both verbally and in writing.
Experience leading conversations with customers (internal and external).
Strong organizational and time management skills. Prioritization and problem solving skills.
Strong knowledge of Quality procedures, processes and guidelines. Recognized by colleagues as a source of expertise.
Able to interpret data.
Perform assigned, complex and / or varied tasks.
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.