About this role
Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
The Senior QA Specialist (f/m/d) Qualification/Validation/EM is ensuring that all processes for facility, equipment, utilities and systems qualification/validation comply with cGMP requirements and internal/external quality standards over the entire life cycle. As a Quality and Compliance representative, he/she will be a key member in cross-functional technical project teams.
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:
Own all Quality and Compliance related responsibilities for the qualification, validation and routine monitoring of the facility, utilities and systems
Coordinate Quality and Compliance objectives during the different project phases (e.g. zone concept, process, cleaning, Environmental Monitoring (EM), etc.)
Identify emerging QA relevant topics, communicate to the Ibex™ QA organization (e.g. new technologies) and work actively on their development into new or already established Quality and Compliance strategies and/or standards
Review and approve Qualification Documents (e.g. Operational Qualification (OQ)/ Performance Qualification (PQ) Plan and Reports, etc.)
Review and approve technical change requests during the different phases of a project and assess their relevance to the qualification of the facility, utilities and systems and ensure investigations and deviations are appropriately investigated and documented
Responsible to drive CAPA (Corrective And Preventive Actions) and Effectiveness Check items to completion and timely closure
Represent EM topics during internal/customer audits and regulatory inspections
Write or revise SOPs in your area of SME and act as owner of such documents
What we are looking for:
Academic degree in Biotechnology/ Pharmacy/ Microbiology/ Chemistry/ Engineering or related field
Significant experience in the area of biopharmaceutical manufacturing preferably in an EM function as well as strong background in cGMP
Broad knowledge of engineering and manufacturing processes
Good communication skills and interaction with all kind of interfaces within the organization and with Health Authorities (Swissmedic, FDA etc.)
Sound experience in representing Quality and Compliance in projects
Strong team orientation
Fluency in English, German would be an asset
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.
Other facts
About Lonza
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
What you'll do
- The Senior QA Specialist is responsible for ensuring compliance with cGMP requirements and internal/external quality standards throughout the qualification and validation processes. This includes coordinating Quality and Compliance objectives, reviewing and approving qualification documents, and representing EM topics during audits.
Ready to join Lonza?
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