QC Compliance Specialist — Microbiology Lab & CAPA

Sanofi Inc.; Waterford; On-site; GBP 47,000 - 73,000; Full time

Job summary

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement, standardization, and regulatory-aligned processes within the QC Lab Team. You will focus on SOP management, deviation handling, CAPA, GMP compliance, and support for LIMS/digital systems to keep the microbiology lab efficient and compliant.

The role requires experience with pharmaceutical regulations (FDA, EMA, ICH), audits, inspections, and strong documentation practices.

Qualifications

• Experience ensuring compliance with pharma regulations (FDA, EMA, ICH)
• Experience in internal audits and regulatory inspections
• Strong understanding of GMP and quality systems

Responsibilities

• Develop and maintain an effective compliance program
• Ensure operations comply with regulatory requirements and standards
• Provide training on compliance topics
• Maintain accurate compliance documentation
• Identify compliance risks and help mitigate them
• Support investigations and reporting of compliance incidents
• Manage CAPA to prevent recurrence

Skills

Regulatory compliance

Audits & inspections

CAPA management

Documentation

Education

Bachelor's degree in Life Sciences or related field

Job description

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement, standardization, and regulatory-aligned processes within the QC Lab Team. You will focus on SOP management, deviation handling, CAPA, GMP compliance, and support for LIMS/digital systems to keep the microbiology lab efficient and compliant.

The role requires experience with pharmaceutical regulations (FDA, EMA, ICH), audits, inspections, and strong documentation practices.