Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
In order to support the strategic growth investment of the company in Visp, we are looking for an experienced Quality leader responsible for the CSV aspects of our CAPEX projects portfolio.
What you will get:
An agile career and a dynamic work culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Visp: https://bit.ly/3wjkoFi
The QA Manager CSV manages all Quality and Compliance related aspects for the computerized systems and furthermore the validation of Syncade and DeltaV recipe objects used for cGMP activities
Owns all quality related responsibilities for the Computerized System Validation (CSV) activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs.
Representative of Quality in the CAPEX project organization in regards to CSV
Reviews and releases of CSV documents and SOPs.
Be a Subject Matter Expert (SME) and provides guidance and recommendations to internal or external customers
Academic degree in Biotechnology/ Chemistry/ Life Science or related field
Significant experience in the GMP regulated pharmaceutical industry; preferably in a role within a Quality Unit
Broad knowledge in CSV, Data Integrity and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)
Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
Working knowledge of ERP (SAP), MES (Syncade) and DCS (DeltaV) is essential
Working knowledge of Recipe Testing & Verification (RTV) is essential
Excellent verbal, written and interpersonal communications skills
Fluency in English, German would be an advantage
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.