Quality Systems Specialist, Raw Materials

Spain, Porrino

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 offer a position for continuous growth and learning facing challenges related to new industry standards, regulations, and customer requirements within the Quality Unit.

You will be a subject matter expert for one or more areas and you will represent the Quality Unit and act as a liaison between the Quality Unit and its internal and external customers.

You will ensure site compliance with cGMP and track Materials related tasks, manage project commitments, follow through on action items, and participates in problem solving of issues.

Your tasks:

  • Quality approver of Quality controlled documents. Provide support to all area in regards with GMP questions

  • Provide support to Global Supplier Quality for supplier’s information, audits and Quality Agreements with regards to raw materials

  • Technical writer, reviewer and approver of documents related to materials such as materials codification forms, material specifications and SOPs

  • Participate in BOM meetings as Quality System representative. Track and compile material data, ensuring deliverable in timely manner.

  • Management of materials (e.g. raw materials set up, Change request, Vendor change notifications, Qualification, Deviations/investigations, Suppliers including contract labs)

  • Act as advisor to testing areas for meeting schedules or resolving problems. Ensure regulatory and customer inspection readiness and represent the department and participate in audits/inspections as required.

  • Provide support to tasks related to Internal / external audits and inspections, Gap Analysis, Quality Alerts, Risk assessments

What you bring to the role:

  • BSc, MSc or PhD preferably in Chemistry or similar field

  • 5 – 10 years experience in pharmaceutical / biotechnology industry, within Qlab or Quality Assurance in a GMP controlled environment. Specifically, we ask for experience with Raw Materials:

    • Strong knowledge and use of Pharmacopeias, GxP regulations and industry standards.

    • Material set up.

    • Setting of specifications.

    • Qualification.

    • Management of Suppliers: classification, quality agreements, audits.

  • Management of quality systems such as change controls, CAPAs, documentation and electronic systems (e.g. TrackWise, DMS)

  • Strong written and oral communication skills in English including public speaking. Strong organizational and time management skills. Ability to manage multiple priorities.

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: R39377