Quality Assurance Specialist (Fixed-term)

About the role

The Quality Assurance Specialist will support Roche’s pharmaceutical quality system, ensuring compliance with the Roche Pharmaceutical Quality System, local GxP regulations and ISO standards. The role is fixed‑term and focuses on maintaining uninterrupted supply of safe, high‑quality products to patients.

Key responsibilities

• Conduct regular management reviews of the QMS and track performance against standards.
• Implement and adapt quality system procedures in line with ISO and divisional SOPs.
• Identify, investigate and resolve discrepancies using established quality systems.
• Manage changes to processes, personnel or systems, assess impact and communicate actions.
• Lead local CAPA activities: root‑cause analysis, corrective/preventive actions and effectiveness checks.
• Perform quality risk assessments, apply mitigation measures and monitor outcomes.
• Maintain data‑integrity SOPs and support internal and external audits, including mock recalls.
• Oversee product complaint handling, batch release, and support clinical trial material distribution.
• Provide GxP training to relevant personnel and keep up‑to‑date with PQS knowledge.

Required profile

• Proven experience working with pharmaceutical quality systems and GxP regulations.
• Ability to conduct audits, risk assessments and CAPA processes.
• Strong understanding of ISO standards applicable to pharma (e.g., ISO 9001, ISO 13485).
• Excellent analytical and communication skills for cross‑functional collaboration.

Required skills

• Quality Management System (QMS) operation
• CAPA management
• ISO 9001 / ISO 13485 compliance
• GxP regulatory knowledge
• Quality risk assessment tools
• Audit execution and reporting
• Data integrity procedures
• Complaint handling systems