QC Compliance & Lab Process Improvement Specialist

Sanofi Inc.; Manchester; Presencial; GBP 51.000 - 77.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Top-tier healthcare

Parental leave (14 weeks)

Career development opportunities

Descripción de la vacante

Sanofi in Waterford, Ireland, is seeking a QC Business Process Specialist to drive continuous improvement, standardization, and regulatory compliance of laboratory business processes. You will focus on SOP management, deviation handling, CAPA and LIMS support to ensure efficient, compliant operations.

You will collaborate with the QC Microbiology team and cross-functional partners to maintain GMP-aligned documentation and support internal audits and regulatory inspections.

Formación

• Experience ensuring compliance with pharmaceutical regulations and standards.
• Experience managing internal audits and regulatory inspections.
• Deep understanding of FDA, EMA, ICH guidelines.

Responsabilidades

• Contribute to development and maintenance of an effective compliance program.
• Ensure operations comply with regulatory requirements and international standards.
• Provide training and guidance on compliance topics.
• Maintain compliance documentation with accuracy and completeness.
• Identify potential compliance risks and help mitigate them.
• Support investigation and reporting of compliance incidents and CAPA.

Conocimientos

Regulatory compliance

Audit management

CAPA handling

Documentation control

Descripción del empleo

Sanofi in Waterford, Ireland, is seeking a QC Business Process Specialist to drive continuous improvement, standardization, and regulatory compliance of laboratory business processes. You will focus on SOP management, deviation handling, CAPA and LIMS support to ensure efficient, compliant operations.

You will collaborate with the QC Microbiology team and cross-functional partners to maintain GMP-aligned documentation and support internal audits and regulatory inspections.