GMP CQV Lead: Qualification & Validation Specialist

Panda International; Oberwallis; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Panda International in Switzerland seeks an experienced CQV specialist to lead commissioning, qualification and validation activities within a GMP-regulated environment. You will develop CQV documentation, perform PQ, and provide ongoing SLC support across projects with internal teams and external providers.

The role requires hands-on CQV expertise, strong documentation, and the ability to defend qualification outcomes during audits and inspections. German and/or English proficiency is essential.

Qualifikationen

• Experience in GMP-regulated pharma/biotech CQV.
• Proven CQV with PQ and CV documentation.
• Strong documentation discipline and audit readiness.

Aufgaben

• Develop and maintain CQV documentation for new plants, facilities and equipment.
• Prepare and execute qualification activities, including PQ for critical systems.
• Provide ongoing System Lifecycle (SLC) support after implementation and qualification.
• Manage deviations, CAPA, change control within GMP.
• Coordinate qualification activities with internal teams and external providers.
• Present and defend qualification documentation during audits and regulatory inspections.
• Support continuous improvement of qualification processes and equipment lifecycle management.
• Independently identify and resolve qualification-related issues while maintaining timelines.

Kenntnisse

CQV

GMP

CAPA

Deviation mgmt

PQ

SLC

Ausbildung

HF/FH or equivalent

Tools

SAP

COMOS

DMS

TrackWise

MS Office

Jobbeschreibung

Panda International in Switzerland seeks an experienced CQV specialist to lead commissioning, qualification and validation activities within a GMP-regulated environment. You will develop CQV documentation, perform PQ, and provide ongoing SLC support across projects with internal teams and external providers.

The role requires hands-on CQV expertise, strong documentation, and the ability to defend qualification outcomes during audits and inspections. German and/or English proficiency is essential.