Global Quality Engineering Senior QA Specialist – Project Delivery

vor 1 Tag

Visp, Schweiz Lonza Group Ltd. Vollzeit

Global Quality Engineering Senior QA Specialist – Project Delivery (m/f/d)

Apply locations CH - Visp time type Full time posted on Posted 5 Days Ago job requisition id R64056

Today, Lonza is a global leader in life sciences operating across five 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.

In order to support the strategic growth investment of the company we are looking for a driven quality leader responsible for the equipment & facilities qualification aspects of our CAPEX projects portfolio. Join our phenomenal team in the heart of Switzerland

The role is based in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Key responsibilities:
  • Own quality related responsibilities for the commissioning and qualification (C&Q) activities of dedicated new and modified facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs.
  • Representative of Quality in the CAPEX project organization in regards to qualification of facilities, utilities, equipment and systems (incl. computerized systems).
  • Provide quality oversight in review and approvals for project documentation (URS, EDRA, DQ, IV/IQ, OFT/OQ, final reports, risk/gap assessments).
  • Be a Subject Matter Expert (SME) and provides guidance and recommendations to project stakeholders related to SOPs, standards, change management, test incident resolution.
Key requirements:
  • Bachelor, Master degree or PhD or equivalent experience in biotechnology, chemistry, life science, engineering or related field.
  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit in CAPEX project environment.
  • Broad knowledge in qualification of equipment, facilities, utilities (biopharmaceuticals & APIs) and related Guidelines (e.g. ASTM, ISPE, GAMP).
  • Proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal.
  • Excellent verbal, written and interpersonal communications skills, Proficiency in English, German is an advantage.
  • Ideally you have experience in Operations, Commissioning & Qualification execution, Engineering and/ or audit/inspection.
  • Knowledge of Kneat is a plus.

Why Lonza?

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.

Inclusion is one of Lonza’s core values. We understand the value of our differences and the benefits they bring to our company, community, and culture. We recognize the value of every person’s contribution, regardless of characteristics, preferences, and beliefs – including race, color, ethnicity, sexual orientation, gender identity, and religion.

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