Senior GMP Validation Specialist (CQV) – Contract, Switzerland

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

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.