QA Validation Specialist

CTC Resourcing Solutions AG seeks a QA Validation Specialist for an on-site contract role in Sion, Switzerland, focusing on GMP compliance and validation lifecycle management.

The company is a global leader in producing and supporting active pharmaceutical ingredients within chemical and biotechnology fields. This position supports that mission by ensuring equipment, facilities, and systems remain compliant with regulatory standards through rigorous validation and quality oversight.

Responsibilities

• Oversee validation and qualification processes to keep GMP equipment, facilities, and systems in a compliant state.
• Evaluate change controls for GMP-related assets and their validation activities to ensure adherence to regulations.
• Create validation protocols based on established validation plans.
• Provide technical review and approval for SOPs, protocols, reports, change controls, deviations, and other documentation.
• Manage tasks within quality systems, including DMS, LIMS, Kneat, and Trackwise.
• Support audits and inspections to verify compliance with EU and US FDA regulations.
• Organize personal workload and assign tasks to Level 1 staff as directed by the Validation Manager.

Requirements

• Hold Swiss or EU citizenship, or possess a valid working/residency permit for Switzerland.
• Have prior experience in GMP-regulated pharmaceutical, biotech, or cell & gene therapy settings.
• Possess 2 to 6 years of experience in validation and qualification.
• Understand the IQ/OQ/PQ lifecycle, maintaining validated states, change control, and documentation review.
• Demonstrate experience reviewing and approving SOPs, validation protocols and reports, deviations, CAPAs, and change controls.
• Be familiar with EU GMP and FDA regulatory requirements.
• Have proficient English communication skills.

Nice to have

• Ability to communicate in German.
• A science or technical degree in engineering, biotechnology, chemistry, biology, pharmacy, or a related discipline.

About the company

The client operates as a global market leader in the production and process support of active pharmaceutical ingredients, serving the chemical and biotechnology sectors.