Senior Qualifying Specialist

Panda International; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, is seeking a Senior Qualifying Specialist to contribute to commissioning, qualification, and validation of new process equipment and facilities. You will drive continuous improvement, support audits, and ensure compliant operations in a fast-paced GMP environment.

Responsibilities include developing qualification documents, managing changes, deviations, CAPAs, and coordinating with internal teams and external providers to deliver quality projects on schedule.

Qualifikationen

• Experience in a regulated GMP environment focusing on commissioning, qualification and validation of systems.
• Ability to develop and maintain commissioning/qualification documents for new plants and equipment.
• Strong written and verbal communication; capable of supporting audits and inspections.

Aufgaben

• Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems and ongoing SLC support post-implementation.
• Supervise deviations, manage changes (GEP and GMP), and implement CAPAs effectively.
• Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
• Present qualification documents during audits and inspections, showcasing high standards.

Kenntnisse

GMP experience

Qualification & validation

Documentation skills

Ausbildung

HF/FH or University degree

Tools

MS Office

COMOS

DMS

Kneat

TrackWise

SAP

Jobbeschreibung

Senior Qualifying Specialist Location: Visp, Onsite Join our team at Lonza in Visp, Switzerland as a Senior Qualifying Specialist. Work alongside an outstanding team dedicated to maintaining flawless operations and premier standards. This role provides an exciting chance to contribute to our dynamic environment, directly improving the quality and efficiency of our processes. Take part in qualifying and validating brand-new process engineering equipment and facilities, promoting continuous improvement and innovation.

Key responsibilities

• Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems and ongoing SLC support post-implementation.
• Supervise and resolve deviations, manage changes (GEP and GMP), and implement CAPAs effectively.
• Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
• Present qualification documents during audits and inspections, showcasing the outstanding standards maintained.

Qualifications

• Graduate from a technical school (HF) / university of applied sciences (FH) or hold a university degree.
• Proven experience in a regulated GMP environment, specifically in commissioning, qualification, and validation of systems like refrigerators, freezers, clean media, and process engineering equipment.
• Strong proficiency in MS Office; familiarity with COMOS, DMS, Kneat, TrackWise, and SAP is advantageous.
• Proficient in both written and spoken German and/or English.
• Demonstrate independent, flexible work habits, with excellent communication skills and a structured, focused approach to tasks.
• Open to new ideas, agile in thinking, and proactive in problem-solving.