Quality Assurance Validation Specialist (7014)

CTC Resourcing Solutions AG seeks a Quality Assurance Validation Specialist for a contract role in Visp, Switzerland. The position supports a GMP manufacturing project, focusing on qualification and validation activities to ensure compliance and system integrity.

This role supports a major GMP manufacturing project in Visp, Switzerland, by ensuring all equipment, facilities, utilities, and systems remain validated and compliant with regulatory standards.

Responsibilities

• Provide quality assurance oversight for qualification and validation (CQV) activities.
• Maintain validated status of GMP equipment, facilities, utilities, and systems.
• Review and approve validation documentation, including protocols, reports, SOPs, deviations, CAPAs, and change controls.
• Evaluate changes affecting validated systems to ensure regulatory compliance.
• Support qualification and validation efforts for IQ, OQ, PQ, clean utilities, autoclaves, temperature mapping, controlled storage, and shipping validation.
• Participate in audits, inspections, and continuous improvement projects.
• Use quality systems including TrackWise, Kneat, DMS, and LIMS.
• Coordinate and prioritize validation-related tasks with project stakeholders.

Requirements

• 2 to 6 years of experience in validation or qualification within a GMP-regulated pharmaceutical or biotechnology setting.
• Solid knowledge of the validation lifecycle, IQ/OQ/PQ processes, maintaining systems in a validated state, change control, and documentation review/approval.
• Experience reviewing and approving SOPs, validation protocols, reports, deviations, CAPAs, and change controls.
• Familiarity with EU GMP and FDA regulatory requirements.