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 both the chemical and biotechnology sectors, is seeking a QA Validation Specialist for a contract position until the end of 2026 (with the option for extension) in the Valais area, Switzerland.

The QA Validation Specialist is responsible for ensuring that GMP equipment, facilities, and systems are properly qualified, validated, and maintained in a compliant state. This role encompasses support through change control, documentation review, audits, and regulatory inspections to ensure product quality and patient safety.

Main Responsibilities:

• Possess a comprehensive understanding of the duties related to Qualifications (CQV) and Validation.
• Perform QA oversight of Validation review and qualification activities to ensure GMP equipment, facilities, and/or systems are continuously maintained in a validated/qualified state.
• Schedule tasks to be performed, including those for Level 1 staff, as determined by the Validation Manager.
• Conduct change control assessments for GMP equipment, facilities, and/or systems, along with associated validation activities to ensure compliance with regulatory requirements.
• Demonstrate thorough knowledge of Cell and Gene manufacturing equipment, facilities, and/or systems, and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, and Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from Validation plans (if applicable).
• Provide strong technical expertise when reviewing and approving SOPs, protocols, reports, change controls, deviations, and other records.
• Perform assigned Quality Systems activities, including Document Management System (DMS), Laboratory Information Management System (LIMS), and Validation and Qualification Management System (Kneat), along with Trackwise system (Change Control, Deviations, CAPA, etc.).
• Participate in audits and inspections to demonstrate compliance of the facility, equipment, and systems with both European and US (FDA) regulations, alongside continuous improvement initiatives.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU citizenship required.
• Quality Assurance / CQV professionals with 15-20 years of overall experience in GMP-regulated pharmaceutical and biopharmaceutical manufacturing sites.
• Thorough understanding of: IQ (Installation Qualification) / OQ (Operational Qualification) / PQ (Performance Qualification) / Validation lifecycle / Maintaining systems in a validated state / Change Control Experience / Documentation Review Experience.
• 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 level of German.
• Academic background is not essential, provided the candidate has the relevant working experience, but ideally with a Science or Technical Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or a related field.

If you would like to learn more about CTC and the opportunity outlined, please apply online using the form below. Only applications matching the job profile will be considered.