QC Compliance & Process Improvement Specialist

Sanofi Inc.; New Gate; On-site; GBP 47,000 - 64,000; Full time

Job summary

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement and compliance of laboratory business processes within the QC Microbiology team. Focus areas include SOP management, deviations, CAPA, GMP, and LIMS/digital systems support.

You will ensure operations meet regulatory requirements, provide training on compliance topics, maintain accurate documentation, and support audits and inspections by regulators and customers in a fast-paced biopharma

Qualifications

• Experience ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Experience in managing internal audits and external regulatory inspections.
• In-depth understanding of pharmaceutical regulations (FDA, EMA, ICH).

Responsibilities

• 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-related topics.
• Maintain compliance documentation with accuracy and completeness.
• Identify potential compliance risks and help mitigate them.
• Support investigation and reporting of compliance incidents; manage CAPA to prevent recurrence.

Skills

Regulatory compliance

GMP knowledge

CAPA management

Audit readiness

Documentation

Tools

LIMS

Job description

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement and compliance of laboratory business processes within the QC Microbiology team. Focus areas include SOP management, deviations, CAPA, GMP, and LIMS/digital systems support.

You will ensure operations meet regulatory requirements, provide training on compliance topics, maintain accurate documentation, and support audits and inspections by regulators and customers in a fast-paced biopharma