QC Analyst – Analytical Chemistry & HPLC (GMP)

Sanofi Inc.; Bath; On-site; GBP 36,000 - 46,000; Full time

Job summary

Sanofi Waterford hires a QC Analyst on a fixed-term, full-time basis to provide analytical services supporting diverse manufacturing operations. You will engage with the Continuous Improvement programme to optimise the laboratory function while complying with regulatory and safety guidelines.

The role requires a degree in science (chemistry or biochemistry preferred), with at least two years of HPLC/Empower experience and familiarity with cGLP, pharmacopoeial methods, and SOPs.

Qualifications

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

Responsibilities

• Provide analytical chemistry services to Site.
• Interact with departments on materials, intermediates and finished batch releases.
• Maintain and update chemical methods, specifications and SOPs in line with pharmacopoeial/regulatory requirements.
• Assist with training of analysts in new methods and SOPs.
• Trend results and record on COAs; investigate OOS promptly.
• Update QC Team Leader on potential problems and improvements.
• Ensure testing equipment meets validation requirements (IQ/OQ/PQ) where required.
• Audit and review chemistry test results daily and ensure GLP compliance.
• Ensure quality documentation and records are complete and current.
• Support new product introduction projects.

Skills

HPLC

Empower

Quality management

Regulatory/compliance

Project management

Pharmaceutical QA experience

Education

Degree in Science (Chemistry or Biochemistry preferred)

Post-graduate studies relevant to degree

Tools

HPLC Tools

Job description

Sanofi Waterford hires a QC Analyst on a fixed-term, full-time basis to provide analytical services supporting diverse manufacturing operations. You will engage with the Continuous Improvement programme to optimise the laboratory function while complying with regulatory and safety guidelines.

The role requires a degree in science (chemistry or biochemistry preferred), with at least two years of HPLC/Empower experience and familiarity with cGLP, pharmacopoeial methods, and SOPs.