QA Validation Specialist – Biologics GMP Expansion (Contract)

Panda International; Oberwallis; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Panda International in Switzerland invites a QA Validation Specialist to join a small core team supporting an expansion of biologics manufacturing. You will ensure GMP equipment, facilities and systems are qualified, validated, and maintained, and you will participate in change control, documentation review, audits and regulatory inspections.

Ideal candidates have 2–6 years in Validation/Qualification, knowledge of OQ and PQ, and familiarity with EU GMP and FDA rules.

Qualifikationen

• 2–6 years of Validation / Qualification experience.
• Experience with EU GMP and FDA regulations.
• English proficiency required; German language skills are an advantage.
• Academic degree not mandatory if relevant industry experience is demonstrated.

Aufgaben

• Oversee QA of validation/qualification activities to maintain validated state.
• Plan and manage assigned validation tasks with the Validation Manager.
• Conduct change control assessments for GMP equipment, facilities, and systems.
• Review SOPs, protocols, reports, deviations, CAPAs and other quality records.
• Participate in audits, inspections, and continuous improvement initiatives.

Kenntnisse

CQV & Validation

QA oversight

Change control

Documentation review

Regulatory inspections

GMP compliance

Biologics manufacturing knowledge

OQ & PQ

Tools

DMS

LIMS

Validation mgmt systems

Jobbeschreibung

Panda International in Switzerland invites a QA Validation Specialist to join a small core team supporting an expansion of biologics manufacturing. You will ensure GMP equipment, facilities and systems are qualified, validated, and maintained, and you will participate in change control, documentation review, audits and regulatory inspections.

Ideal candidates have 2–6 years in Validation/Qualification, knowledge of OQ and PQ, and familiarity with EU GMP and FDA rules.