Overview
QA Validation Specialist Jobs in Visp, Valais, Switzerland at Randstad Switzerland
Title: QA Validation Specialist
Company: Randstad Switzerland
Location: Visp, Valais, Switzerland
Our client, pharmaceutical company in Visp, is looking for a QA Validation Specialist:
Role Title: QA Validation Specialist I (Qualifications)
Contract Duration: ASAP – December 31, 2026
Location: Visp (CH)
Role Overview
The QA Validation Specialist I provides QA oversight for Commissioning, Qualification, and Validation (CQV) activities. This role ensures all GMP equipment, facilities, and systems remain compliant with process parameters, user requirements, and global regulatory standards (FDA/EMA), particularly within Cell and Gene Therapy operations.
Key Responsibilities
- QA Oversight & Scheduling: Oversee validation reviews and schedule daily qualification tasks for self and Level 1 team members as directed by the Validation Manager.
- CQV & Protocol Execution: Develop and approve protocols/reports (IQ, autoclaves, clean utilities, shipping validation, and temperature mapping for controlled storage).
- Quality Systems: Review and approve SOPs, change controls, deviations, and CAPAs using TrackWise, Kneat, DMS, and LIMS.
- Compliance & Audits: Conduct change control assessments and support regulatory audits (FDA/EMA) to maintain continuous facility compliance.
Requirements
- Education: Bachelor’s degree in a Scientific or Technical discipline.
- Experience: 2–6 years of pharmaceutical industry experience with direct exposure to CQV and GMP environments.
- Technical Expertise: Hands-on experience with equipment qualification (IQ, temperature mapping, utilities) and Quality Systems software (Kneat, TrackWise).
- Languages: English (fluent required); German (a strong plus).
