GMP CQV QA Validation Specialist (Contract, Switzerland)

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Zusammenfassung

The Life Science Career Network 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 qualified, validated, and maintained, with oversight of change control and regulatory inspections.

Ideal candidates have extensive CQV/validation experience in pharmaceutical or biopharmaceutical manufacturing, plus knowledge of IQ/OQ/PQ and related lifecycle processes, and are proficient in

Qualifikationen

• Relevant working/residency permit for Switzerland/EU
• 15–20 years of experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing
• Experience with IQ/OQ/PQ and Validation lifecycle

Aufgaben

• Oversee QA of Validation activities to maintain validated state of GMP equipment/facilities/systems
• Schedule tasks for self and for Level 1 per Validation Manager
• Perform change control assessments to ensure regulatory compliance
• Review and approve SOPs, validation protocols, reports, deviations and CAPAs
• Support audits and regulatory inspections in EU and FDA contexts
• Manage documentation within DMS, LIMS, Kneat and Trackwise systems

Kenntnisse

CQV

Validation

IQ/OQ/PQ

Change Control

Documentation Review

GMP

Audit readiness

Regulatory Inspections

English/German

Ausbildung

Science/Engineering degree

Tools

DMS

LIMS

Kneat

Trackwise

Jobbeschreibung

The Life Science Career Network 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 qualified, validated, and maintained, with oversight of change control and regulatory inspections.

Ideal candidates have extensive CQV/validation experience in pharmaceutical or biopharmaceutical manufacturing, plus knowledge of IQ/OQ/PQ and related lifecycle processes, and are proficient in