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Senior QA Compliance Specialist

Novartis

Novartis

Legal, Quality Assurance
Austria
Posted on Friday, February 2, 2024

About the Role

Location: Novartis, Schaftenau, Austria

About the Role:

The Complaint Specialist is responsible for performing complaint investigations (initial assessments, escalations, investigations and approval). The Complaint Specialist is responsible for identifying improvements of complaints across all products. The Complaint Specialist is accountable for the management of samples and all related activities. The Complaint Specialist also ensures the GxP compliance of all relevant quality systems, participates in external and internal audits and is responsible for the application of health, safety and quality standards in all aspects of the position.

Key Responsibilities:

Your responsibilities include, but are not limited to:
• Accountable for investigating technical and mixed product complaints and for the quality of the investigations.
• Responsible for coordinating the actions of different departments to complete the investigations and for prioritizing the workload to meet deadlines
• Support for the approval and closure of complaints; accountable for the sample management process.
• Responsible for identifying improvement opportunities and support implementation
• Support the standardization of the complaint processes and the implementation of the process for new products and supporting the complaint team in preparing for internal/external audits
• Responsible for keeping complaint procedures and work instructions up-to-date with current regulation and global procedures/quality manuals; Key member during the escalation of complaints
• Support the different country organization in identifying product trends and preventive/corrective actions to decrease potential issues
• Support the communication between complaints and key stakeholders and in training new employees of the complaints team; support other functions as required