Pharma QC Analyst – Analytical Chemistry (Waterford, Fixed-Term)

Sanofi Inc.; Southampton; On-site; GBP 36,000 - 51,000; Full time

Job summary

Sanofi Waterford seeks a QC Analyst on a fixed-term, full-time basis to provide analytical services supporting our manufacturing operations. You will collaborate with QA, Production and Engineering to ensure timely batch releases and compliance with pharmacopoeial standards.

You will maintain and update methods and SOPs, train analysts, trend results, and assist with OOS investigations, audits and new product introductions.

Qualifications

• Degree in Science (Chemistry or Biochemistry preferred).
• Operational experience of quality laboratories in a fast-moving manufacturing environment.
• Knowledge of quality management systems, pharmacopoeial methods and cGLP.
• 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 QA, Production, Engineering and Planners on material and batch releases.
• Maintain, update and issue methods, specifications and SOPs in compliance with pharmacopoeial/regulatory requirements.
• Assist with training of the analysts in areas of expertise and new methods.
• Trend results, record on COAs, and complete OOS investigations promptly.
• Update QC Team Leader on potential problems and improvements via normal communication.
• Ensure equipment validation (IQ/OQ/PQ) where required.
• Audit and review chemistry test results daily and ensure cGLP compliance.
• Ensure quality documentation and records are complete and current.
• Support new product introduction projects.

Skills

Quality systems knowledge

Regulatory compliance

Project management

Laboratory operations

cGLP awareness

Education

Bachelor's degree in Chemistry/Biochemistry

Post-graduate qualification

Tools

HPLC/Empower

Job description

Sanofi Waterford seeks a QC Analyst on a fixed-term, full-time basis to provide analytical services supporting our manufacturing operations. You will collaborate with QA, Production and Engineering to ensure timely batch releases and compliance with pharmacopoeial standards.

You will maintain and update methods and SOPs, train analysts, trend results, and assist with OOS investigations, audits and new product introductions.