Qualification & Validation

Gi Group; Oberwallis; Hybrid; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CQV expertise

GMP experience

Documentation

Project coordination

Independent work

Ausbildung

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

Tools

Kneat

TrackWise

SAP

COMOS

DMS

Jobbeschreibung

Senior Qualification Specialist (CQV)

Start Date: ASAP

Location: Visp, Switzerland

About the Role

Our client, a leading pharmaceutical and biotechnology company, is seeking a Senior Qualification Specialist to join its team in Visp, Switzerland.

In this role, you will be responsible for supporting commissioning, qualification, and validation activities for GMP-regulated equipment and facilities. You will play a key role in ensuring compliance, operational excellence, and the successful delivery of critical projects within a fast-paced manufacturing environment.

Key Responsibilities

• Develop, review, and maintain Commissioning, Qualification, and Validation (CQV) documentation.
• Execute and approve IQ, OQ, and PQ protocols for critical systems and equipment.
• Lead and support deviation investigations, CAPAs, and Change Control activities.
• Manage equipment and system lifecycle activities following implementation.
• Coordinate qualification activities with internal stakeholders, suppliers, and external service providers.
• Support audits, inspections, and regulatory submissions by presenting qualification documentation.
• Ensure compliance with GMP requirements, internal procedures, and industry best practices.
• Drive continuous improvement initiatives to enhance quality, compliance, and operational efficiency.

Requirements

• Bachelor’s degree or higher in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical field.
• Minimum 5 years of experience in a GMP-regulated environment with a strong background in Commissioning, Qualification & Validation (CQV).
• Experience qualifying process equipment, clean utilities, refrigerators, freezers, and critical GMP systems.
• Solid knowledge of GMP regulations, Change Control, Deviations, Investigations, and CAPA processes.
• Proficiency with MS Office; experience with Kneat, TrackWise, SAP, COMOS, or DMS is considered an advantage.
• Fluent in English; German is a strong asset.
• Strong organizational, communication, and problem-solving skills.
• Ability to work independently while collaborating effectively within multidisciplinary teams.