Quality Investigations Lead: Root-Cause & CAPA Excellence

Sanofi Inc.; Waterford; On-site; GBP 56,000 - 73,000; Full time

Job summary

Sanofi is seeking an Investigation Lead to join our PFS Operations team in Waterford, Ireland. You will lead technical and product quality investigations to identify root causes and implement proactive corrective actions, acting as SME for the Investigation System and related tools.

Responsibilities include driving deviations and CAPAs, data analysis, and cross-functional collaboration with shift teams and stakeholders to ensure right-first-time documentation and continuous quality improvement.

Qualifications

• Knowledge of cGMP in a regulated environment.
• Working knowledge of quality systems in a regulated environment.
• Sterile manufacturing experience would be beneficial.
• System investigation experience.
• Excellent accuracy and attention to detail.
• Excellent interpersonal skills.
• Problem solving skills.

Responsibilities

• Lead technical and product quality investigations to identify true root causes and implement preventative actions.
• Complete investigations to quality standards within required timeframes.
• Facilitate cross-functional investigations on shift and act as SME for Investigation System and tools.
• Conduct data collation, trending and analysis to identify improvements.
• Drive timely closure of deviations, commitments and CAPAs; trend customer complaints to identify corrective actions.
• Act as shift team coach and drive a culture of compliance and continuous improvement.
• Escalate significant issues and participate in key decisions with stakeholders.
• Provide SME support for systems, technologies and products.
• Coordinate with shift and process teams to ensure on-time investigation completion.
• Support quality systems operations and conduct audits as needed.

Skills

cGMP knowledge

Quality systems knowledge

Sterile manufacturing

System investigation

Attention to detail

Interpersonal skills

Problem solving

Job description

Sanofi is seeking an Investigation Lead to join our PFS Operations team in Waterford, Ireland. You will lead technical and product quality investigations to identify root causes and implement proactive corrective actions, acting as SME for the Investigation System and related tools.

Responsibilities include driving deviations and CAPAs, data analysis, and cross-functional collaboration with shift teams and stakeholders to ensure right-first-time documentation and continuous quality improvement.