QC Compliance & Process Improvement Specialist

Sanofi; Waterford; Hybrid; EUR 48,000 - 64,000; Full time

Benefits offered by this job

Healthcare benefits

Parental leave

Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to strengthen the QC Microbiology lab by driving SOP/procedure management, deviation and CAPA handling, and GMP compliance. You will support LIMS and digital systems to ensure efficient, compliant operations aligned with regulatory requirements.

The role emphasizes training, documentation, and cross-functional collaboration across global quality and regulatory teams, with a focus on maintaining robust, audit-ready

Qualifications

• Experience ensuring compliance with local, national and international pharmaceutical regulations and standards.
• Experience managing internal audits and external regulatory inspections, including prep, execution and follow-up.
• In-depth understanding of pharmaceutical regulations, guidelines and standards (FDA, EMA, ICH).

Responsibilities

• Contributing to an effective compliance program.
• Ensuring operations comply with regulatory requirements and international standards.
• Providing training and guidance on compliance topics to employees.
• Maintaining compliance documentation for accuracy and completeness.
• Identifying potential compliance risks and helping develop mitigation strategies.
• Supporting investigation and reporting of compliance incidents.
• Managing CAPA to address incidents and prevent recurrence.

Skills

Regulatory compliance

Audit management

Quality systems

GxP knowledge

Tools

LIMS

Job description

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to strengthen the QC Microbiology lab by driving SOP/procedure management, deviation and CAPA handling, and GMP compliance. You will support LIMS and digital systems to ensure efficient, compliant operations aligned with regulatory requirements.

The role emphasizes training, documentation, and cross-functional collaboration across global quality and regulatory teams, with a focus on maintaining robust, audit-ready