QA Validation Specialist

Coopers Group AG seeks a Mid-level QA Validation Specialist in Switzerland to oversee GMP equipment and system qualification, ensuring regulatory compliance through rigorous review and audit participation.

This position focuses on the quality assurance oversight of validation and qualification processes for cell and gene manufacturing environments. The specialist ensures that GMP equipment, facilities, and systems remain in a validated state while managing change controls and participating in regulatory inspections.

Responsibilities

• Oversee validation reviews and qualification activities to maintain GMP equipment, facilities, and systems in a compliant state.
• Manage personal workload and assign tasks to Level 1 staff as directed by the Validation Manager.
• Evaluate change controls for GMP assets and related validation work to guarantee adherence to regulatory standards.
• Create validation protocols based on established validation plans where necessary.
• Provide technical guidance during the review and approval of SOPs, protocols, reports, change controls, deviations, and other documentation.
• Execute quality system duties using tools such as the Document Management System (DMS), Laboratory Information Management System (LIMS), Kneat for validation management, and Trackwise for change control, deviations, and CAPA.
• Support audits and inspections to prove compliance with European and US FDA regulations and drive continuous improvement.

Requirements

• Background in GMP-regulated sectors including pharmaceuticals, biotechnology, or cell and gene therapy.
• Two to six years of experience in validation and qualification, covering IQ, OQ, PQ, and maintenance activities.
• Proven track record of reviewing and approving SOPs, validation protocols and reports, deviations, CAPAs, and change controls.
• Knowledge of EU GMP and FDA regulatory frameworks.
• Strong proficiency in English.

Nice to have

• Ability to communicate in German.