Pharma QC Analyst - Flexible Hours, Growth & Impact

Sanofi Inc.; Bedford; On-site; GBP 34,000 - 51,000; Full time

Job summary

Sanofi is seeking a QC Analyst for a fixed-term, full-time position at our Waterford site. The role focuses on providing analytical chemistry services to support manufacturing operations and continuous improvement within the QC department.

The successful candidate will work with QA, production, engineering and planners to ensure compliance with cGLP and regulatory requirements, maintain methods and SOPs, and train analysts in new techniques.

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, 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 and support to Site.
• Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
• Close contact with Quality Assurance Production, Engineering and Planners.
• Maintain, update and issue chemical methods, specifications and SOPs in compliance with pharmacopoeial and regulatory requirements.
• Assist with training of analysts in areas of expertise, new methods, SOPs and updates.
• Trend such results, record on COAs and complete OOS investigations timely.
• Update QC Team Leader on potential problems and improvements via standard communication channels.
• Ensure critical chemical testing and related equipment meet current validation requirements (IQ, OQ, PQ).
• Audit and review chemistry test results daily and ensure compliance with cGLP.
• Ensure all quality documentation and records are complete and current.
• Support new product introduction projects.

Job description

Sanofi is seeking a QC Analyst for a fixed-term, full-time position at our Waterford site. The role focuses on providing analytical chemistry services to support manufacturing operations and continuous improvement within the QC department.

The successful candidate will work with QA, production, engineering and planners to ensure compliance with cGLP and regulatory requirements, maintain methods and SOPs, and train analysts in new techniques.