Microbiology QC Process Improvement Specialist

Sanofi Inc.; Northampton; On-site; GBP 47,000 - 64,000; Full time

Job summary

Sanofi Waterford invites applications for a QC Business Process Specialist within our QC Lab Team. You will drive continuous improvement, SOP management, deviation and CAPA handling, GMP compliance, and support LIMS/digital systems to keep Microbiology operations efficient and compliant.

You will collaborate across QA and operations, train staff on compliance topics, maintain documentation, and help mitigate risks by implementing robust CAPA actions and incident investigations.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations and standards.
• Experience managing internal audits and regulatory inspections.
• 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 other 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 investigation and reporting of compliance incidents.
• Managing CAPA to address incidents and prevent recurrence.

Skills

Regulatory compliance

Audit and inspections

CAPA management

Documentation control

Job description

Sanofi Waterford invites applications for a QC Business Process Specialist within our QC Lab Team. You will drive continuous improvement, SOP management, deviation and CAPA handling, GMP compliance, and support LIMS/digital systems to keep Microbiology operations efficient and compliant.

You will collaborate across QA and operations, train staff on compliance topics, maintain documentation, and help mitigate risks by implementing robust CAPA actions and incident investigations.