QA Validation Specialist

About the role

Join a transformative GMP expansion project in Switzerland as a QA Validation Specialist. You will ensure that equipment, facilities and systems are qualified, validated and maintained in line with regulatory standards, supporting product quality and patient safety.

Key responsibilities

• Oversee validation and qualification activities for GMP equipment, facilities and systems.
• Schedule and manage tasks for yourself and Level 1 team members under the Validation Manager.
• Conduct change‑control assessments and develop validation protocols.
• Review and approve SOPs, validation protocols, reports, change controls, deviations and CAPAs.
• Maintain documentation and tracking tools such as DMS, LIMS, Kneat and Trackwise.
• Participate in audits and inspections to demonstrate compliance with EU GMP and FDA regulations.
• Provide technical expertise in IQ, OQ, PQ, autoclaves, clean utilities, shipping validation, temperature mapping and controlled storage rooms.
• Support continuous‑improvement initiatives.

Required profile

• Experience in GMP‑regulated pharmaceutical, biotech or cell‑and‑gene‑therapy environments.
• Strong understanding of the validation lifecycle (IQ, OQ, PQ) and change‑control processes.
• Familiarity with EU GMP and FDA regulations.
• Ability to work autonomously in a fast‑paced, multicultural setting.
• Proficiency in English; German is a strong plus.

Required skills

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• DMS (Document Management System)
• LIMS (Laboratory Information Management System)
• Kneat
• Trackwise