GMP Deviations Specialist (Temporary) CAPA & Root Cause

Eupro AG; Visperterminen; Vor Ort; CHF 90.000 - 120.000; Teilzeit

Zusammenfassung

Eupro AG in Visp is seeking a Deviations Specialist to strengthen quality activities in a GMP biopharmaceutical setting. The role focuses on management, investigation and closure of deviations in a large-scale mammalian cell culture facility.

This temporary position starts early August and lasts five months. Key tasks include CAPA, root cause analysis, collaboration with SMEs, and ensuring timely deviation lifecycle compliance within a regulated environment.

Qualifikationen

• Bachelor's degree in Chemistry, Biotechnology, Life Sciences or equivalent scientific field.
• Experience in deviation management and GMP/cGMP environment within the pharmaceutical/biotech/API industry.
• Knowledge of biotechnological manufacturing processes and analytical methods.
• Experience with root cause analysis, risk management and HOP approaches is a plus.
• Excellent command of English (spoken and written); German is a plus.

Aufgaben

• Manage, investigate and close deviations in GMP biopharma.
• Identify root causes and evaluate quality impacts.
• Represent Operations in deviation processes.
• Ensure timely processing and closing of deviations.
• Write, record, and track deviations through lifecycle.
• Collaborate with SMEs and stakeholders.
• Assess impact on products, processes, equipment, or quality systems.
• Apply structured problem-solving and QRM tools.
• Define and implement CAPAs.
• Monitor CAPA effectiveness and prevent recurrence.
• Support change and process optimization projects.
• Strengthen quality culture and GMP compliance.
• Support operational improvement initiatives.

Kenntnisse

Analytical skills

Written & verbal communication

English proficiency

German knowledge

Ausbildung

Bachelor's degree in Chemistry/Life Sciences

Jobbeschreibung

Eupro AG in Visp is seeking a Deviations Specialist to strengthen quality activities in a GMP biopharmaceutical setting. The role focuses on management, investigation and closure of deviations in a large-scale mammalian cell culture facility.

This temporary position starts early August and lasts five months. Key tasks include CAPA, root cause analysis, collaboration with SMEs, and ensuring timely deviation lifecycle compliance within a regulated environment.