QC Compliance & Process Improvement Specialist

Sanofi Inc.; Bradford; On-site; GBP 45,000 - 69,000; Full time

Benefits offered by this job

Top-tier healthcare

Parental leave 14 weeks

Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to support the QC Microbiology lab by driving continuous improvement, standardization, and regulatory compliance of laboratory business processes.

You will focus on SOP management, deviation and CAPA handling, GMP compliance, and digital systems such as LIMS. Collaboration with cross-functional teams and training of staff are key to ensure operations run efficiently and in line with regulatory guidelines.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations and standards.
• Experience managing internal audits and regulatory inspections.
• Understanding of FDA, EMA, ICH guidelines.

Responsibilities

• Contribute to development and maintenance of an effective compliance program.
• Ensure operations comply with regulatory requirements and 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.

Skills

Compliance management

Regulatory understanding

Audits & inspections

Stakeholder communication

Tools

LIMS

Job description

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to support the QC Microbiology lab by driving continuous improvement, standardization, and regulatory compliance of laboratory business processes.

You will focus on SOP management, deviation and CAPA handling, GMP compliance, and digital systems such as LIMS. Collaboration with cross-functional teams and training of staff are key to ensure operations run efficiently and in line with regulatory guidelines.