Deviation Specialist

BioTalent; Oberwallis; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

BioTalent is seeking a Deviation Specialist to support quality investigations in a GMP-regulated production environment. You will manage deviations, perform root cause analyses, drive CAPA implementation, and collaborate with technical experts to ensure compliance and continuous improvement.

The role requires a degree in Life Sciences or related field, plus experience in GMP settings and strong analytical/communication skills to drive quality systems forward.

Qualifikationen

• Degree in Life Sciences, Biotechnology, Chemistry, or related field.
• Experience within GMP-regulated pharmaceutical or biotech environments.
• Knowledge of deviation management and quality systems.
• Strong analytical, technical writing, and communication skills.

Aufgaben

• Manage and investigate deviations.
• Perform root cause investigations using recognised methodologies.
• Assess quality and compliance impact.
• Coordinate with technical and operational stakeholders.
• Define CAPAs and effectiveness measures.
• Support quality records through to closure.
• Contribute to process improvement initiatives.

Kenntnisse

Deviation management

Root cause analysis

CAPA

Technical writing

Communication

Quality systems

GMP experience

Ausbildung

Bachelor's degree in Life Sciences, Biotechnology, Chemistry, or related field

Jobbeschreibung

A global biotechnology manufacturing organisation is seeking a Deviation Specialist to support quality investigations within a GMP-regulated production environment.

The successful candidate will manage quality deviations, perform root cause analyses, drive CAPA implementation, and collaborate with technical experts to ensure compliance and continuous improvement.

Responsibilities

• Manage and investigate deviations.
• Perform root cause investigations using recognised methodologies.
• Assess quality and compliance impact.
• Coordinate with technical and operational stakeholders.
• Define CAPAs and effectiveness measures.
• Support quality records through to closure.
• Contribute to process improvement initiatives.

Requirements

• Degree in Life Sciences, Biotechnology, Chemistry, or related field.
• Experience within GMP-regulated pharmaceutical or biotech environments.
• Knowledge of deviation management and quality systems.
• Strong analytical, technical writing, and communication skills.