Quality Assurance Validation Specialist (7014)
QA Validation Specialist – 7014
Our client, a leading pharmaceutical and biotechnology company, is currently recruiting for a QA Validation Specialist to support a major GMP manufacturing project in Visp, Switzerland.
As a QA Validation Specialist, you will provide QA oversight of qualification and validation activities, ensure compliance of GMP systems and equipment, and support change controls, deviations, and validation documentation throughout the project lifecycle. This is a 5-month contract starting on 1st or 7th of July 2026 fully on site.
Key Responsibilities
- Provide QA oversight for qualification and validation (CQV) activities.
- Ensure GMP equipment, facilities, utilities, and systems remain in a validated and compliant state.
- Review and approve validation documentation, including protocols, reports, SOPs, deviations, CAPAs, and change controls.
- Assess changes impacting validated systems and ensure regulatory compliance.
- Support qualification and validation activities related to:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Clean Utilities
- Autoclaves
- Temperature Mapping
- Controlled Storage Areas
- Shipping Validation
- Participate in audits, inspections, and continuous improvement initiatives.
- Utilize quality systems such as TrackWise, Kneat, DMS, and LIMS.
- Coordinate and prioritize validation-related activities in collaboration with project stakeholders.
Required Experience
- 2–6 years of experience in Validation / Qualification within a GMP-regulated pharmaceutical or biotechnology environment.
- Strong understanding of:
- Validation lifecycle
- IQ / OQ / PQ
- Maintaining systems in a validated state
- Change Control
- Documentation review and approval processes
- Experience reviewing and approving:
- SOPs
- Validation Protocols
- Validation Reports
- Deviations
- CAPAs
- Change Controls
- Familiarity with EU GMP and FDA requirements.