QA Validation Specialist (7041)

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions seeks a QA Validation Specialist for a contract role in Valais, Switzerland. You will oversee GMP equipment and systems qualification, ensure compliant validation, and support change control, audits, and inspections to safeguard patient safety.

The ideal candidate has extensive CQV/validation experience in pharma and can navigate EU GMP and FDA standards, with English and German language proficiency.

Qualifikationen

• 15–20 years of experience in GMP-regulated pharmaceutical/biopharma manufacturing.
• Understanding IQ (Installation Qualification), OQ, PQ and the validation lifecycle.
• Experience reviewing SOPs, validation protocols, validation reports, deviations and CAPAs.
• Familiar with EU GMP and FDA regulations.
• English proficiency and German language skills are desirable.

Aufgaben

• Oversee QA oversight of validation activities to keep GMP equipment/facilities in a validated state.
• Manage change control assessments and regulatory-compliant validation activities.
• Review and approve SOPs, protocols, reports, deviations and CAPAs.
• Coordinate with Validation Manager and QA on task scheduling and audits.

Kenntnisse

Quality Assurance

CQV concepts

GMP knowledge

Documentation review

Regulatory awareness

Ausbildung

Science or Technical Degree preferred

Tools

Kneat

LIMS

DMS

Trackwise

Jobbeschreibung

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.