QC Compliance & Process Specialist

Sanofi Inc.; High Wycombe; Sur place; GBP 45 000 - 58 000; Plein temps

Avantages offerts par ce poste

Health benefits

Parental leave 14 weeks

AI-powered science and innovation

Résumé du poste

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland. You will drive continuous improvement and standardization of laboratory business processes within the QC Lab, focusing on SOP management, deviation handling, GMP compliance, and LIMS/digital systems support to ensure efficiency and regulatory alignment.

The role emphasizes training, documentation, risk assessment, and collaboration across teams to maintain a compliant environment and support quality goals in a fast-paced

Qualifications

• Experience ensuring compliance with pharmaceutical regulations and standards.
• Experience in managing internal audits and regulatory inspections, including preparation and follow-up.
• Deep understanding of FDA, EMA, ICH guidelines.

Responsabilités

• Contribute to development and maintenance of an effective compliance program.
• Ensure all operations comply with regulatory requirements and international standards.
• Provide training and guidance on compliance topics.
• Maintain compliance documentation with accuracy and completeness.
• Identify compliance risks and help develop mitigation strategies.
• Support investigation and reporting of compliance incidents.
• Manage CAPA to address incidents and prevent recurrence.

Connaissances

Compliance

Regulatory knowledge

Audit management

Documentation

Description du poste

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland. You will drive continuous improvement and standardization of laboratory business processes within the QC Lab, focusing on SOP management, deviation handling, GMP compliance, and LIMS/digital systems support to ensure efficiency and regulatory alignment.

The role emphasizes training, documentation, risk assessment, and collaboration across teams to maintain a compliant environment and support quality goals in a fast-paced