QC Compliance & Process Optimization Specialist

Sanofi Inc.; Dartford; Vor Ort; GBP 51.000 - 69.000; Vollzeit

Zusammenfassung

Sanofi is seeking a QC Business Process Specialist for the Waterford, Ireland site. You will support the QC Microbiology team by driving continuous improvement, standardization, and compliance of laboratory business processes, including SOPs and digital systems alignment.

The role focuses on GMP compliance, CAPA handling, deviation management, and LIMS support to ensure efficient, compliant operations in the Microbiology lab environment.

Qualifikationen

• Experience ensuring compliance with local, national, and international pharmaceutical regulations and standards (FDA/EMA/ICH).
• Experience managing internal audits and regulatory inspections, including preparation, execution, and follow-up.
• Strong knowledge of GMP and regulatory requirements for laboratory operations.

Aufgaben

• Contributing to the development and maintenance of an effective compliance program.
• Ensuring all operations comply with regulatory requirements and other international standards.
• Providing training and guidance to employees on compliance-related topics.
• Maintaining compliance-related documentation, ensuring accuracy and completeness.
• Identifying potential compliance risks and contributing to mitigation strategies.
• Supporting the investigation and reporting of compliance incidents.
• Managing CAPA to address compliance issues and prevent recurrence.

Kenntnisse

Regulatory compliance

SOP management

CAPA handling

GMP knowledge

LIMS/digital systems

Tools

LIMS

Jobbeschreibung

Sanofi is seeking a QC Business Process Specialist for the Waterford, Ireland site. You will support the QC Microbiology team by driving continuous improvement, standardization, and compliance of laboratory business processes, including SOPs and digital systems alignment.

The role focuses on GMP compliance, CAPA handling, deviation management, and LIMS support to ensure efficient, compliant operations in the Microbiology lab environment.