QC Microbiology Process & Compliance Specialist

Sanofi Inc.; Portsmouth; On-site; GBP 51,000 - 77,000; Full time

Job summary

Sanofi is seeking a QC Business Process Specialist to strengthen our QC Microbiology operations in Waterford, Ireland. You will drive SOP management, CAPA handling, and GMP compliance, ensuring alignment with regulatory requirements and robust documentation.

You will support LIMS/digital systems and contribute to a compliant, efficient lab environment. The role emphasizes continuous improvement, standardization and collaboration with cross-functional QA teams to mitigate risks and enhance

Qualifications

• Experience in ensuring compliance with local, national and international pharmaceutical regulations and standards.
• Experience in managing internal audits and external regulatory inspections, including preparation, execution and follow-up.
• Strong understanding of GMP, QA/QC processes and regulatory guidelines (FDA, EMA, ICH).

Responsibilities

• Drive SOP and procedure management to support QC microbiology operations.
• Maintain compliant documentation and CAPA management.
• Support audits, inspections and regulatory readiness.
• Assist in deviation investigation and corrective action tracking.
• Support LIMS and digital systems to improve lab efficiency and data integrity.

Skills

Communication

Attention to detail

Root cause analysis

Project management

Job description

Sanofi is seeking a QC Business Process Specialist to strengthen our QC Microbiology operations in Waterford, Ireland. You will drive SOP management, CAPA handling, and GMP compliance, ensuring alignment with regulatory requirements and robust documentation.

You will support LIMS/digital systems and contribute to a compliant, efficient lab environment. The role emphasizes continuous improvement, standardization and collaboration with cross-functional QA teams to mitigate risks and enhance