QC Process Excellence & Compliance Specialist

Sanofi Inc.; Newcastle upon Tyne; Sur place; GBP 39 000 - 51 000; Plein temps

Avantages offerts par ce poste

Health benefits and well-being

14 weeks gender-neutral parental leave

Résumé du poste

Sanofi Waterford QC team is seeking a QC Business Process Specialist to drive continuous improvement and standardization of laboratory business processes. You will focus on SOP management, deviation handling, CAPA, and regulatory alignment across GMP requirements and LIMS/digital systems.

The role involves supporting the Microbiology lab operations to ensure efficiency, compliance, and traceability, with emphasis on documentation, audits, and training across the global regulatory landscape.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations and standards (FDA/EMA/ICH).
• Experience with internal audits and regulatory inspections; preparation, execution and follow-up.

Responsabilités

• Assist in developing and maintaining compliant business processes within QC Lab.
• Drive SOP/procedure management and CAPA handling.
• Support GMP compliance and LIMS/digital systems.
• Maintain accurate, complete compliance documentation and training materials.
• Identify compliance risks and support mitigation strategies.
• Investigate and report compliance incidents and manage CAPA to prevent recurrence.

Connaissances

Communication

Attention to detail

Root cause analysis

Project management

Description du poste

Sanofi Waterford QC team is seeking a QC Business Process Specialist to drive continuous improvement and standardization of laboratory business processes. You will focus on SOP management, deviation handling, CAPA, and regulatory alignment across GMP requirements and LIMS/digital systems.

The role involves supporting the Microbiology lab operations to ensure efficiency, compliance, and traceability, with emphasis on documentation, audits, and training across the global regulatory landscape.