QC Analyst — Pharma, Flexible Working & Quality Impact

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

Job summary

Sanofi Waterford QC Analyst role seeks an analytical chemist to provide chemistries support for diverse manufacturing operations. You will interact with QA, Production, Engineering and Planners to ensure smooth batch releases and robust methods in line with cGLP.

You will train analysts, update SOPs and specifications, and contribute to continuous improvement initiatives while maintaining documentation and regulatory compliance across the site.

Qualifications

• Degree in Science (Chemistry or Biochemistry preferred).
• Post-graduate studies to augment primary degree.
• Operational experience of quality laboratories in a fast-moving manufacturing environment.
• Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, cGLP and pharmacopoeial methods.
• Understand relevant quality/compliance regulations.
• Can manage projects to plan/budget.
• Minimum two years HPLC/Empower experience.

Responsibilities

• Provide analytical chemistry services and support to Site.
• Interact with other departments on materials, intermediates and finished batch releases.
• Maintain contact with QA, Production, Engineering and Planners.
• Update chemical methods, specifications and SOPs to comply with pharmacopoeial and regulatory requirements.
• Assist with training of analysts in areas of expertise and new methods.
• Trend results, record on COAs, and investigate OOS promptly.
• Update QC Team Leader on potential problems and improvements.
• Ensure testing and related equipment meet current validation (IQ/OQ/PQ).
• Audit and review chemistry results daily and ensure quality documentation is complete.
• Support new product introduction projects.

Skills

Analytical thinking

Quality mindset

Regulatory understanding

Project management

Communication

HPLC/Empower experience

Education

Bachelor's degree in Chemistry or Biochemistry

Post-graduate studies

Tools

Empower software

Job description

Sanofi Waterford QC Analyst role seeks an analytical chemist to provide chemistries support for diverse manufacturing operations. You will interact with QA, Production, Engineering and Planners to ensure smooth batch releases and robust methods in line with cGLP.

You will train analysts, update SOPs and specifications, and contribute to continuous improvement initiatives while maintaining documentation and regulatory compliance across the site.