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Stein (AR), Appenzell Ausserrhoden, Schweiz/Suisse/Svizzera/Svizra
Onsite
The actual location of this job is in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
In order to support our business growth in Stein (Switzerland), we are looking for a Quality Assurance Manager with expertise in Drug Product systems qualification, QC analytical equipment qualification and CSV & Automation. The successful candidate will be joining a cross-functional and international team for a large aseptic fill-finish facility project. The main responsibilities are listed below, but not limited to and might be adapted depending on project priorities
What you’ll get:
An agile career and a dynamic work culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
What you will do:
Responsible for Equipment, QC, Computerized System Validation (CSV) and Automation deliverables for new aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products
Representing Quality in the CAPEX project organization in regards to Equipment, QC, Computerized System Validation (CSV) and Automation and Automation
Reviewing and releasing quality related to Equipment, QC, Computerized System Validation (CSV) and Automation project deliverables
Ensuring Equipment, QC, Computerized System Validation (CSV) and Automation deliverables meet Global procedures, regulatory requirements and policies
Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal and external project stakeholders
What we are looking for:
Bachelor or Master degree in computer science, engineering, life science or related field
Significant experience in the GMP regulated pharmaceutical industry project; preferable in a role within a Quality Unit
Knowledgeable in commissioning and qualification of aseptic manufacturing systems and QC analytical systems, Annex 1 requirements
Knowledgeable in CSV, Data Integrity, Automation systems 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.)
Sound knowledge of MES and DCS is required
Fluency in English, German would be an advantage
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.