QA Validation Specialist / QA Validation Specialistess

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QA Validation Specialist

Our client, a global market leader in the production and process support of active pharmaceutical ingredients in the chemical and biotechnology sectors, is seeking a QA Validation Specialist for a contract position until the end of 2026, with the possibility of extension, in the Valais area of Switzerland.

The QA Validation Specialist will be responsible for ensuring that GMP equipment, facilities, and systems are properly qualified, validated, and maintained in compliance, supported through change control, documentation review, audits, and regulatory inspections to guarantee product quality and patient safety.

Main Responsibilities:

• Possess a comprehensive understanding of the duties related to Qualifications (CQV) and Validation.
• Conduct QA oversight of validation reviews and qualification activities to ensure GMP equipment, facilities, and systems remain in a validated state.
• Schedule personal tasks as well as tasks for Level 1 as determined by the Validation Manager.
• Perform change control assessments for GMP equipment, facilities, and systems to ensure compliance with regulatory requirements.
• Demonstrate a thorough understanding of Cell and Gene manufacturing equipment and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, and Temperature Mapping.
• Develop validation protocols from Validation plans, where applicable.
• Provide technical expertise in reviewing and approving SOPs, protocols, reports, change controls, deviations, and other relevant records.
• Engage in assigned Quality Systems activities including Document Management System (DMS), Laboratory Information Management System (LIMS), Validation and Qualification Management System (Kneat), and Trackwise system (Change Control, Deviations, CAPA, etc.).
• Participate in Audits and inspections to demonstrate compliance with both European and US (FDA) regulations, contributing to continuous improvement initiatives.

Qualifications and Experience:

• Relevant working or residency permit or Swiss/EU citizenship is required.
• 15-20 years of experience in Quality Assurance/CQV within GMP-regulated pharmaceutical and biopharmaceutical manufacturing environments.
• A sound understanding of IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), validation lifecycle, maintaining systems in a validated state, change control, and documentation review.
• Experience in reviewing and approving SOPs, validation protocols, validation reports, deviations, CAPAs, and change controls.
• Familiarity with EU GMP and FDA regulations.
• Proficiency in English and a good command of German.
• A Science or Technical Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or a related field is preferred, but not essential if accompanied by relevant work experience.

Application Process

If you wish to learn more about CTC and the opportunity outlined above, please apply online using the form below. Please note that only applications matching the job profile will be considered.