Senior CQV Specialist — GMP Validation & Compliance

Gi Group; Oberwallis; Hybrid; CHF 110,000 - 150,000; Full time

Job summary

Gi Group is seeking a Senior Qualification Specialist (CQV) for its client in Visp, Switzerland. The role focuses on commissioning, qualification and validation activities for GMP-regulated equipment and facilities in a fast-paced manufacturing setting.

You will develop CQV documentation, execute IQ/OQ/PQ, and drive deviations, CAPAs, and Change Control while coordinating with internal teams and suppliers. Fluency in English is required; German is a strong asset.

Qualifications

• Bachelor’s degree or higher in Engineering, Life Sciences, Biotechnology, or related field.
• Minimum 5 years in a GMP-regulated CQV environment.
• Experience qualifying process equipment, clean utilities, refrigerators and critical systems.
• Strong GMP knowledge: Change Control, Deviations, Investigations, CAPA.
• MS Office proficient; Kneat/TrackWise/SAP/COMOS/DMS a plus.
• Fluent in English; German is a strong asset.

Responsibilities

• Develop, review, and maintain CQV documentation.
• Execute IQ, OQ, PQ protocols for critical systems and equipment.
• Lead deviation investigations, CAPAs, and Change Control activities.
• Manage lifecycle activities for equipment and systems post-implementation.
• Coordinate qualification with internal and external stakeholders.
• Support audits and regulatory submissions with qualification docs.
• Ensure GMP compliance and align with procedures and best practices.
• Drive continuous improvement for quality, compliance, and efficiency.

Skills

CQV expertise

GMP experience

Documentation

Project coordination

Independent work

Education

Bachelor’s degree or higher in Engineering/Life Sciences/Pharmaceuticals

Tools

Kneat

TrackWise

SAP

COMOS

DMS

Job description

Gi Group is seeking a Senior Qualification Specialist (CQV) for its client in Visp, Switzerland. The role focuses on commissioning, qualification and validation activities for GMP-regulated equipment and facilities in a fast-paced manufacturing setting.

You will develop CQV documentation, execute IQ/OQ/PQ, and drive deviations, CAPAs, and Change Control while coordinating with internal teams and suppliers. Fluency in English is required; German is a strong asset.