Quality Investigations Lead - Right-First-Time

Sanofi; Munster; On-site; EUR 65,000 - 90,000; Full time

Job summary

Sanofi in Waterford, Ireland, seeks an Investigation Lead to drive technical and product quality investigations, identifying true root causes and delivering sustainable corrective actions.

You will act as a role model for quality and safety culture on the shift, partnering with internal and external stakeholders on product quality and safety In this role you will lead cross-functional investigations, support quality systems operations, and ensure timely closure of deviations and CAPAs while

Qualifications

• Knowledge of cGMP in a regulated environment.
• Working knowledge of quality systems in a regulated environment.
• Sterile manufacturing experience is beneficial.
• Experience with system investigations and remediation.
• Excellent accuracy and attention to detail.
• Strong interpersonal and problem-solving skills.

Responsibilities

• Lead investigations to identify root causes and implement corrective actions.
• Complete investigations within required timeframes.
• Facilitate cross-functional investigations on shift using Gemba tools.
• Analyze data to identify process and system improvements.
• Drive CAPAs and close deviations in a timely manner.
• Coach shift teams to uphold compliance and continuous improvement.
• Escalate significant issues and support decision-making.
• Provide SME support for systems, technologies, and products.
• Coordinate with shift and process teams for on-time investigations.
• Support audits and monitor documentation right-first-time performance.

Skills

cGMP knowledge

Quality systems

Sterile manufacturing

Investigation experience

Attention to detail

Interpersonal skills

Problem solving

Job description

Sanofi in Waterford, Ireland, seeks an Investigation Lead to drive technical and product quality investigations, identifying true root causes and delivering sustainable corrective actions.

You will act as a role model for quality and safety culture on the shift, partnering with internal and external stakeholders on product quality and safety In this role you will lead cross-functional investigations, support quality systems operations, and ensure timely closure of deviations and CAPAs while