Quality Customer Project Expert (m/f/d)

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.

Here in Porrino (situated 20min from Vigo), we are looking for an experienced Quality Customer Projects Expert to join our ever expanding, highly successful team.

You will be responsible for managing customer projects within Quality Unit (QU) area, Representing the Quality Unit in multi-disciplinary customer project teams ensuring that all the projects fulfills quality standards, adherence to timeline and scope and on time and in full deliverables during the project lifecycle and acting as a liaison between the customer and different departments within QU and other project´s stakeholders, coordinating technical SMEs throughout all stages of the projects balancing customer needs and business goals.

Key responsibilities:

  • Quality representative in the different multidisciplinary teams for customer projects being responsible for the actions follow-up and any deliverable for the project team.

  • Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner.

  • Create, review and approval of process documentation as required (i.e. specifications, sampling plans).

  • Creation, review and approval (as applicable) of Stability Protocols and Reports.

  • APR (annual product review) management.

  • Management of complaints and product recall

  • Lot Disposition

  • Monitoring of the final product from the quality perspective (ISAs/OOC/OOT management as applicable) and Continued Process Verification (CVP) contribution.

  • Lead/collaborate with Test method transfer managing master protocol and report.

  • In close collaboration with the program manager ensure that project amendments are accurate and workload estimation is correctly assessed.

  • Ensure regulatory and customer inspection readiness and represent the department and participate in audits/inspections as required.

Key requirements:

  • Bachelor of Science (Pharmacy, Chemistry, Biology, Biotechnology, Biochemistry…etc) or proven experience in Quality Field

  • Several years (at least 5 years)  of work experience in the pharmaceutical industry (preferably within Quality Assurance) experience in a GMP environment and Quality systems.

  • Experience in the communication with external clients and projects management

  • Statistical knowledge (e.g. experience in statistically evaluating data from the manufacturing- or quality control departments - identifying trends and presenting the data to various stakeholders) is a strong advantage

  • A very good command of the English and Spanish languages (written and verbal)

  • Good comunication skills

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: R56543