QC Compliance & Process Specialist (Microbiology)

Sanofi Inc.

Wolverhampton

On-site

GBP 47,000 - 60,000

Full time

14 days+
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Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to drive continuous improvement, standardization, and compliance of laboratory business processes within the QC Microbiology team. The role emphasizes SOP/procedure management, deviation handling, and GMP compliance across LIMS and digital systems.

You will support the Microbiology lab to operate efficiently, in alignment with regulatory requirements, through training, documentation, and risk-based approach to CAPA and

Qualifications

  • Experience ensuring compliance with pharmaceutical regulations and standards.
  • Experience managing internal audits and regulatory inspections, including preparation, execution, and follow-up.
  • In-depth understanding of FDA, EMA, ICH guidelines.

Responsibilities

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

Skills

Regulatory compliance
CAPA management
Audit management
GMP compliance
LIMS

Tools

LIMS

Job description

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to drive continuous improvement, standardization, and compliance of laboratory business processes within the QC Microbiology team. The role emphasizes SOP/procedure management, deviation handling, and GMP compliance across LIMS and digital systems.

You will support the Microbiology lab to operate efficiently, in alignment with regulatory requirements, through training, documentation, and risk-based approach to CAPA and

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