QA Validation Specialist (7041 – KFR)

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 105.000 - 145.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a QA Validation Specialist for a contract role in the Valais region of Switzerland. The position focuses on ensuring GMP equipment, facilities and systems are properly qualified, validated and maintained in a compliant state.

Responsibilities include QA oversight of validation activities, change control assessments, and reviews of SOPs and validation documentation. The candidate should bring extensive CQV expertise and fluency in English with German language

Qualifikationen

• 15–20 years of experience in GMP-regulated pharmaceutical manufacturing sites.
• Experience with IQ/OQ/PQ lifecycle and validation.
• Familiar with EU GMP and FDA regulations.
• English proficiency and good German level.
• Residency permit or Swiss/EU citizenship required.
• Academic background in science or engineering preferred.

Aufgaben

• Oversee QA reviews of validation activities to ensure GMP equipment, facilities and systems remain validated.
• Maintain qualification status through change control and documentation reviews.
• Schedule tasks and coordinate with Validation Manager for Level 1 activities.
• Perform change control assessments to ensure regulatory compliance.
• Demonstrate understanding of IQ/OQ/PQ and validation procedures for equipment and facilities.
• Develop validation protocols from validation plans when applicable.
• Review SOPs, validation protocols, reports, deviations and CAPAs with rigor.
• Support audits and inspections to demonstrate facility and system compliance with EU GMP and FDA regulations.
• Assist in continuous improvement initiatives.

Kenntnisse

Quality Assurance / CQV

GMP experience

English proficiency

German language

Ausbildung

Science or technical degree (Engineering, Biotechnology, Chemistry, Biology, Pharmacy)

Jobbeschreibung

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

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


• Quality Assurance / CQV professionals with 15-20 overall years of experience in GMP-regulated pharmaceutical and biopharmaceutical manufacturing sites


• 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 and good German level


• 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.