Lonza seeks a Senior QA Qualification Specialist in Visp to lead qualification efforts for new facilities, ensuring compliance with cGMP and regulatory standards through project coordination and documentation.
This position serves as the primary QA Qualification representative within project organizations for new facilities and other initiatives. The specialist supports the QA Plant Qualification team by coordinating cross-functional QA interests and driving the implementation of qualification strategies throughout the project lifecycle.
Responsibilities
- Coordinate various QA interests during the project phase, including process, cleaning, and other relevant QA objectives.
- Lead the implementation of new qualification strategies and make decisive actions when necessary.
- Compile, review, and release Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports) and support/approve quality risk analysis (e.g. FMEA).
- Perform assessments and approvals of technical changes requests during project phases and lifecycle regarding their relevance to qualification.
- Represent qualification topics during customer audits and regulatory inspections.
- Drive CAPA and Effectiveness Checks items to completion and timely closing, and ensure deviations are appropriately investigated and recorded.
Requirements
- Academic degree in Engineering, Chemistry, Biotechnology, or any related field.
- Significant experience in the pharmaceutical industry, ideally in a QA role.
- Fluent German (written and verbal) is required.
Nice to have
- Good understanding of applicable cGMP regulations.
- General knowledge of engineering and manufacturing processes.
- Ability to oversee project execution to identify non-compliance from quality standards.
- Good English language skills.
What the company offers
- Relocation assistance is available for eligible candidates and their families.
- An agile career and a dynamic work culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Numerous lifestyle, family, and leisure benefits.
About the company
Lonza fosters a collaborative and inclusive environment where diversity is valued. The company’s core values of Collaboration, Accountability, Excellence, Passion, and Integrity guide its operations, encouraging innovation through unique perspectives from all backgrounds.
- Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
- The company values diversity and is committed to creating an inclusive environment for all employees.
- Innovation thrives when people from all backgrounds bring unique perspectives.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.