QC Analyst - Biopharma Chemistry & Method Development

Sanofi Inc.; Liverpool; On-site; GBP 28,000 - 44,000; Full time

Job summary

Sanofi Waterford site is seeking a QC Analyst on a fixed-term, full-time basis to deliver analytical chemistry services supporting manufacturing operations. You will engage with Continuous Improvement, maintain methods and SOPs, and collaborate with QA, Engineering and Planners to ensure quality releases.

The role requires a Chemistry/Biochemistry degree, HPLC/Empower experience and strong knowledge of cGLP and pharmacopoeial methods.

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 and support to Site.
• Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
• Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements.
• Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOPs and updates.
• Trend such results, record on COA's where required and complete OOS investigations on a timely basis.
• Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
• Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
• Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
• Ensure all quality documentation and records are complete and current.
• Support new product introduction projects.

Skills

HPLC/Empower experience

Quality laboratory operations

Project management

Regulatory & cGLP understanding

Education

Science degree (Chemistry or Biochemistry)

Post-graduate studies

Tools

Empower LIMS

Job description

Sanofi Waterford site is seeking a QC Analyst on a fixed-term, full-time basis to deliver analytical chemistry services supporting manufacturing operations. You will engage with Continuous Improvement, maintain methods and SOPs, and collaborate with QA, Engineering and Planners to ensure quality releases.

The role requires a Chemistry/Biochemistry degree, HPLC/Empower experience and strong knowledge of cGLP and pharmacopoeial methods.