QC Lab Process & Compliance Specialist

Sanofi; Munster; On-site; EUR 65,000 - 85,000; Full time

Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to support the QC Microbiology team by driving continuous improvement, standardization, and regulatory compliance of laboratory business processes.

The role focuses on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to ensure the Microbiology lab operates efficiently and in full regulatory alignment.

Qualifications

• Experience ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Strong verbal and written communication skills to convey compliance requirements to stakeholders.

Responsibilities

• Contributing to the development and maintenance of an effective compliance program
• Ensuring operations comply with regulatory requirements and international standards
• Providing training and guidance on compliance topics
• Maintaining compliance-related documentation for accuracy and completeness
• Identifying compliance risks and helping mitigate them
• Supporting investigation and reporting of compliance incidents
• Managing CAPA to address incidents and prevent recurrence

Job description

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to support the QC Microbiology team by driving continuous improvement, standardization, and regulatory compliance of laboratory business processes.

The role focuses on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to ensure the Microbiology lab operates efficiently and in full regulatory alignment.