QC Compliance & Process Improvement Specialist

Biopharma Careers; Waterford; On-site; EUR 48,000 - 64,000; Full time

Benefits offered by this job

Top-tier healthcare

14 weeks gender-neutral parental leave

Employee benefit programs

Job summary

Sanofi Waterford is seeking a QC Business Process Specialist within the QC Lab Team to drive continuous improvement, standardization, and compliance of laboratory business processes in a GMP environment.

The role focuses on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to keep the Microbiology lab efficient, compliant, and aligned with regulatory requirements.

Qualifications

• Experience ensuring compliance with pharma regulations and standards.
• Experience managing internal audits and regulatory inspections.
• Strong communication and attention to detail.

Responsibilities

• Contribute to compliance program development and maintenance.
• Ensure operations meet regulatory requirements.
• Provide training on compliance topics.
• Maintain compliance documentation.
• Identify compliance risks and mitigate them.
• Support investigation and reporting of incidents.
• Manage CAPA to prevent recurrence.

Skills

Compliance

CAPA

GMP

SOP management

Regulatory audits

Documentation

Tools

LIMS

Job description

Sanofi Waterford is seeking a QC Business Process Specialist within the QC Lab Team to drive continuous improvement, standardization, and compliance of laboratory business processes in a GMP environment.

The role focuses on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support to keep the Microbiology lab efficient, compliant, and aligned with regulatory requirements.