QA Validation Specialist

About the role

The QA Validation Specialist will join a small core team at a pharmaceutical manufacturing site in Visp, Switzerland. Reporting to the Head of QA Validation & Qualifications, the role supports a major expansion project focused on biologics manufacturing, ensuring that equipment, facilities and systems remain qualified and compliant.

Key responsibilities

• Perform QA oversight of qualification (CQV) and validation activities for GMP equipment, facilities and systems.
• Plan, execute and document validation protocols, including IQ, OQ, PQ and temperature mapping.
• Conduct change‑control assessments and support documentation review for SOPs, protocols, reports, deviations and CAPAs.
• Maintain and operate quality systems such as DMS, LIMS, validation management and change‑control tools.
• Participate in internal and external audits, inspections and continuous‑improvement initiatives to meet EU and US regulatory requirements.

Required profile

• 2–6 years of experience in validation/qualification within a GMP‑regulated pharmaceutical, biotech or cell‑&‑gene‑therapy environment.
• Strong knowledge of IQ, OQ, PQ, validation lifecycle management and change‑control processes.
• Familiarity with EU GMP and FDA regulations.
• Fluent English; German language skills are a strong advantage.
• Relevant academic degree not mandatory if extensive industry experience is demonstrated.

Required skills

• Qualification (CQV) and validation expertise
• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Change‑control assessment and documentation review
• EU GMP and FDA regulatory knowledge
• Document Management Systems (DMS)
• Laboratory Information Management Systems (LIMS)
• Validation and Qualification Management Systems
• CAPA and deviation management
• Temperature mapping of controlled storage rooms and equipment