Senior QA Qualification Specialist

(Senior) QA Qualification Specialist 80-100% (f/m/d)

Location:

Visp, Switzerland

We are looking for a (Senior) QA Specialist Qualification (f/m/d), who will support our team QA Plant Qualification.

• 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.

Benefits in Visp: (Use the "Apply for this Job" box below)./3wjkoFi

• 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 OR vocational education with strong relevant experience.
• 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.

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.

Reference: R71652