Quality Complaints Specialist: Root Cause & CAPA

Sanofi Group; Waterford; Hybrid; EUR 55,000 - 73,000; Full time

Job summary

Sanofi Waterford is seeking a Quality Complaints Specialist for a 23-month FTC on-site role. You will coordinate complaint handling, investigate issues, and communicate with customers to ensure timely resolutions while maintaining compliance across the site.

You will analyze data, identify root causes, implement CAPA, and collaborate with cross-functional teams to drive continuous improvement in product quality and customer satisfaction.

Qualifications

• Experience in Quality Assurance or Quality Control within the pharmaceutical industry
• Ability to analyze complex data sets and identify trends to improve complaint handling processes

Responsibilities

• Support the implementation and maintenance of the complaint management process
• Assist in investigations into product complaints, including root cause analysis and CAPA
• Communicate with customers regarding status and resolution of complaints
• Document and maintain records of complaint management activities and communications
• Collaborate with cross-functional teams to address and resolve complaints
• Analyze complaint data to identify trends and potential areas for product improvement
• Support audits and inspections by providing required information related to complaint management
• Ensure process performance with other entities/sites involved in the management of complaints at the site level

Skills

Data analysis

Root cause analysis

CAPA implementation

Cross-functional collaboration

Education

Degree qualification in Pharmaceutical Sciences, Quality, or a related discipline

Job description

Sanofi Waterford is seeking a Quality Complaints Specialist for a 23-month FTC on-site role. You will coordinate complaint handling, investigate issues, and communicate with customers to ensure timely resolutions while maintaining compliance across the site.

You will analyze data, identify root causes, implement CAPA, and collaborate with cross-functional teams to drive continuous improvement in product quality and customer satisfaction.