CQV Validation Lead – Biologics GMP Expansion

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

Zusammenfassung

Panda International is seeking an experienced QA Validation Specialist for a major GMP manufacturing expansion in Visp, Switzerland. You will oversee qualification and validation activities to ensure that equipment, facilities, and systems remain qualified and compliant throughout their lifecycle.

You will collaborate with Operations, Engineering, and Regulatory bodies, applying CQV principles including IQ, OQ and PQ, and manage change controls while reviewing GMP documentation and supporting

Qualifikationen

• Experience in GMP environments and QA validation.
• Proven ability to review and approve GMP documentation (SOPs, protocols, reports).
• Strong knowledge of IQ/OQ/PQ and validation lifecycle.
• Proactive, autonomous with excellent communication.

Aufgaben

• Provide QA oversight of validation/qualification activities for GMP equipment, facilities and systems.
• Ensure systems remain validated throughout their lifecycle.
• Perform and assess change controls related to qualification activities.
• Develop validation protocols based on approved plans where required.
• Review and approve GMP documentation including deviations and CAPAs.
• Support audits and regulatory inspections (EU GMP, US FDA).
• Collaborate with Operations, Engineering, Validation and project stakeholders.

Kenntnisse

QA Validation

Change Control

Documentation Review

Regulatory Compliance

Stakeholder Management

Ausbildung

Degree in Engineering

Biotechnology or Chemistry background

Tools

DMS

LIMS

Kneat

TrackWise

Jobbeschreibung

Panda International is seeking an experienced QA Validation Specialist for a major GMP manufacturing expansion in Visp, Switzerland. You will oversee qualification and validation activities to ensure that equipment, facilities, and systems remain qualified and compliant throughout their lifecycle.

You will collaborate with Operations, Engineering, and Regulatory bodies, applying CQV principles including IQ, OQ and PQ, and manage change controls while reviewing GMP documentation and supporting