Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
We are looking for a (Senior) QA Specialist Qualification (f/m/d), who will support our team QA Plant Qualification.
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
What you will do:Representative of QA Qualification in the project organization for new facilities or other projects in regard to qualification of facilities, utilities, equipment and systems
Coordinating different QA interests during the project phase e.g. process, cleaning or other relevant QA objectives
Driving implementation of new qualification strategy and being a strong decision maker when needed
Compiling, reviewing and releasing Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports and more) as also supporting and approving quality risk analysis (e.g. FMEA)
Performing assessments and approvals of technical changes requests during the different phases of a project and lifecycle and their relevance to the qualification of facilities, equipment, utilities and systems
Representing qualification topics during customer audits and regulatory inspections
Being responsible to drive CAPA and Effectiveness Checks items to completion and timely closing as well ensuring deviations are appropriately investigated and recorded in Deviation Reports
Academic degree in Engineering/ Chemistry/ Biotechnology or any related field
Significant experience in the pharmaceutical industry, ideally in a QA role
Good understanding of the applicable cGMP regulations would be an advantage
General knowledge of engineering and manufacturing processes
Ability to oversee project execution to identify non-compliance from quality standards
Fluent German (written&verbal) is required; good English language skills are 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.
Skills Required
- Academic degree in Engineering, Chemistry, Biotechnology or related field
- Significant experience in the pharmaceutical industry (ideally in QA)
- Good understanding of applicable cGMP regulations
- General knowledge of engineering and manufacturing processes
- Ability to oversee project execution and identify non-compliance with quality standards
- Fluent German (written and verbal)
- Good English language skills
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
