• Contract
  • Valais
  • Recruiter: Karolina Frank

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QA Validation Specialist

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Validation Specialist for a contract position till end of 2026 (with option for extension) in Valais area, Switzerland.

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

Main Responsibilities:

  • Must possess a full grasp of the duties of Qualifications (CQV) and Validation.
  • Perform QA oversight of the Validation review and qualification activities to ensure GMP equipment, facility and/or systems are continuously maintained in a validated/qualified state.
  • Schedule own tasks to be performed as well as tasks for Level 1 as determined by the Validation Manager.
  • Perform change control assessments for GMP equipment, facility and/or systems and associated validation activities to ensure compliance with regulatory requirements.
  • Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, 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), Validation and Qualification Management System (Kneat) and Trackwise system (Change Control, Deviations, CAPA, etc.).
  • Perform other duties as assigned, like participate to Audits and inspections to demonstrate the compliance of the facility, equipment and systems with both European and US (FDA) regulations, and continuous improvement initiatives.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • GMP-regulated pharmaceutical, biotech, or cell & gene therapy environment
  • 2–6 years Validation / Qualification Experience
  • The candidate should understand: IQ (Installation Qualification) / OQ (Operational Qualification) / PQ (Performance Qualification) / Validation lifecycle / Maintaining systems in a validated state / Change Control Experience / Documentation Review Experience
  • Must have experience reviewing and approving: SOPs / Validation protocols / Validation reports / Deviations / CAPAs / Change controls
  • Familiar with EU GMP and FDA regulations
  • English Proficiency (German a strong plus)
  • Academic background not essential provided candidate has the right working experience , but ideally with a Science or Technical Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or related field.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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