QA Validation Specialist

Randstad Switzerland; Oberwallis; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Randstad Switzerland is assisting a Visp-based pharmaceutical client in locating a QA Validation Specialist I (Qualifications). The role focuses on QA oversight for CQV activities, ensuring GMP-compliant equipment, facilities and systems. It requires hands-on qualification work and QA software experience.

The candidate will develop and approve validation protocols, execute IQ and temperature mapping, and support audits by FDA/EMA to maintain ongoing compliance in cell and gene therapy operations.

Qualifikationen

• Bachelor’s degree in a Scientific or Technical discipline is required.
• 2–6 years in pharmaceutical CQV/GMP environments.
• Hands-on equipment qualification (IQ, temp mapping, utilities) and QA systems software experience.

Aufgaben

• Provide QA oversight for CQV activities and validate equipment, facilities and systems.
• Develop and approve IQ and validation protocols/reports (including temperature mapping and autoclaves).
• Review SOPs, change controls, deviations, and CAPAs in QA systems.
• Support regulatory audits (FDA/EMA) to maintain facility compliance.

Kenntnisse

QA Oversight

CQV

Regulatory compliance

GMP

Validation scheduling

Protocol development

Ausbildung

Bachelor's degree in a Scientific or Technical discipline

Tools

TrackWise

Kneat

DMS

LIMS

Jobbeschreibung

Our client, pharmaceutical company in Visp, is looking for a QA Validation Specialist:

Role Title: QA Validation Specialist I (Qualifications)

Contract Duration: ASAP – December 31, 2026

Location: Visp (CH)

Role Overview

The QA Validation Specialist I provides QA oversight for Commissioning, Qualification, and Validation (CQV) activities. This role ensures all GMP equipment, facilities, and systems remain compliant with process parameters, user requirements, and global regulatory standards (FDA/EMA), particularly within Cell and Gene Therapy operations.

Key Responsibilities

• QA Oversight & Scheduling: Oversee validation reviews and schedule daily qualification tasks for self and Level 1 team members as directed by the Validation Manager.
• CQV & Protocol Execution: Develop and approve protocols/reports (IQ, autoclaves, clean utilities, shipping validation, and temperature mapping for controlled storage).
• Quality Systems: Review and approve SOPs, change controls, deviations, and CAPAs using TrackWise, Kneat, DMS, and LIMS.
• Compliance & Audits: Conduct change control assessments and support regulatory audits (FDA/EMA) to maintain continuous facility compliance.

Requirements

• Education: Bachelor’s degree in a Scientific or Technical discipline.
• Experience: 2–6 years of pharmaceutical industry experience with direct exposure to CQV and GMP environments.
• Technical Expertise: Hands-on experience with equipment qualification (IQ, temperature mapping, utilities) and Quality Systems software (Kneat, TrackWise).