Quality & Compliance Process Specialist

Sanofi; Munster; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland to drive continuous improvement and compliance across the QC Microbiology lab. You will manage SOPs, deviations, CAPAs, GMP compliance, and digital systems (LIMS), ensuring efficient operations aligned with regulatory requirements.

You will work on developing and maintaining an effective compliance program, delivering training, and supporting audits and inspections.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations.
• Experience in managing internal audits and external regulatory inspections.
• Familiarity with FDA, EMA, ICH guidelines.

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

Regulatory compliance

GMP knowledge

Communication skills

Attention to detail

Process improvement

Tools

LIMS

Job description

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland to drive continuous improvement and compliance across the QC Microbiology lab. You will manage SOPs, deviations, CAPAs, GMP compliance, and digital systems (LIMS), ensuring efficient operations aligned with regulatory requirements.

You will work on developing and maintaining an effective compliance program, delivering training, and supporting audits and inspections.