Quality Compliance & Process Improvement Specialist

Sanofi; Munster; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Top-tier healthcare

14 weeks gender-neutral parental leave

Job summary

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement of laboratory business processes within the QC Microbiology team. You’ll support SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to ensure the Microbiology lab operates efficiently and in line with regulatory requirements.

This role emphasizes implementing standardized processes, maintaining documentation, and training colleagues to improve

Qualifications

• Experience ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Strong verbal and written communication skills to effectively convey compliance requirements and updates.

Responsibilities

• Contributing to the development and maintenance of an effective compliance program
• Ensuring all operations comply with relevant regulatory requirements and other international standards
• Providing training and guidance to employees on compliance-related topics
• Maintaining compliance-related documentation, ensuring accuracy and completeness
• Identifying potential compliance risks and contributing to the development of strategies to mitigate them
• Supporting the investigation and reporting of compliance incidents
• Managing CAPA to address compliance incidents and preventing recurrence

Skills

Communication skills

Attention to detail

Analytical thinking

Project management

Tools

LIMS

Job description

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement of laboratory business processes within the QC Microbiology team. You’ll support SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to ensure the Microbiology lab operates efficiently and in line with regulatory requirements.

This role emphasizes implementing standardized processes, maintaining documentation, and training colleagues to improve