QC Compliance & Process Improvement Specialist

Sanofi; France; Sur place; EUR 48 000 - 64 000; Plein temps

Avantages offerts par ce poste

Health benefits

14 weeks parental leave

Résumé du poste

Sanofi is seeking a QC Business Process Specialist for its Waterford, Ireland site to enhance and standardize laboratory processes in the QC Microbiology lab. You will oversee SOP/procedure management, CAPA handling, GMP compliance, and LIMS/digital system support, ensuring regulatory alignment and efficiency.

You will drive continuous improvement, train staff on compliance topics, and maintain comprehensive documentation while identifying risks and implementing mitigation strategies to

Qualifications

• Experience ensuring compliance with pharmaceutical regulations (FDA, EMA, ICH).
• Experience managing internal audits and regulatory inspections.

Responsabilités

• Develop and maintain a robust compliance program.
• Ensure operations align with regulatory requirements and international standards.
• Provide training on compliance to staff and stakeholders.
• Maintain accurate compliance documentation and records.
• Identify compliance risks and contribute to mitigation strategies.
• Support investigation and reporting of compliance incidents.
• Manage CAPA to prevent recurrence of issues.

Connaissances

Regulatory compliance

Audit management

Communication

Description du poste

Sanofi is seeking a QC Business Process Specialist for its Waterford, Ireland site to enhance and standardize laboratory processes in the QC Microbiology lab. You will oversee SOP/procedure management, CAPA handling, GMP compliance, and LIMS/digital system support, ensuring regulatory alignment and efficiency.

You will drive continuous improvement, train staff on compliance topics, and maintain comprehensive documentation while identifying risks and implementing mitigation strategies to