Senior QA Qualification Specialist – Visp

Lonza; Stalden (VS); Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, is seeking a (Senior) QA Qualification Specialist (f/m/d) 80-100% to support QA Plant Qualification. This role focuses on qualification of facilities, utilities, equipment and systems within projects, ensuring quality standards are met.

The successful candidate will coordinate QA activities, drive new qualification strategies, review qualification documents (URS, DQ/IQ/OQ/PQ), and support regulatory audits. Fluency in German is required; English is an advantage.

Qualifikationen

• Academic degree in Engineering, Chemistry, Biotechnology or related field.
• Significant pharmaceutical QA experience.
• Strong understanding of cGMP regulations.
• Knowledge of engineering and manufacturing processes.
• Ability to oversee project execution and identify non-compliance.
• German language skills are required; English is an advantage.

Aufgaben

• Representative of QA Qualification in the project organization for new facilities or other projects.
• Coordinate QA interests during the project phase (e.g. process, cleaning).
• Drive implementation of new qualification strategy and decisive actions when needed.
• Compile, review and release Qualification Documents (URS, QP, DQ/IQ/OQ/PQ).
• Support quality risk analyses (e.g. FMEA).
• Assess technical changes during lifecycle with respect to qualification.
• Participate in customer audits and regulatory inspections.
• Drive CAPA and Effectiveness Checks to completion and close deviations.

Kenntnisse

QA Experience

cGMP Knowledge

Project Oversight

German Language

English Advantage

Ausbildung

Engineering/ Chemistry/ Biotechnology or related field

Jobbeschreibung

Lonza in Visp, Switzerland, is seeking a (Senior) QA Qualification Specialist (f/m/d) 80-100% to support QA Plant Qualification. This role focuses on qualification of facilities, utilities, equipment and systems within projects, ensuring quality standards are met.

The successful candidate will coordinate QA activities, drive new qualification strategies, review qualification documents (URS, DQ/IQ/OQ/PQ), and support regulatory audits. Fluency in German is required; English is an advantage.