QC Analyst — Flexible Working (BioPharma Lab)

Sanofi Inc.; Leeds; On-site; GBP 36,000 - 44,000; Full time

Job summary

Sanofi Waterford is seeking a QC Analyst on a fixed-term, full-time basis to support analytical services across manufacturing operations. The role involves ensuring compliance with cGLP, updating methods and SOPs, and collaborating with QA, Production, Engineering and Planners.

You will contribute to continuous improvement, apply HPLC/Empower experience, and uphold high quality standards in a fast-paced biopharmaceutical environment at Waterford campus.

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.
• In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
• 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's 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) whererequired.
• 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

Education

Degree in Science (Chemistry or Biochemistry preferred)

Post-graduate studies as appropriate

Job description

Sanofi Waterford is seeking a QC Analyst on a fixed-term, full-time basis to support analytical services across manufacturing operations. The role involves ensuring compliance with cGLP, updating methods and SOPs, and collaborating with QA, Production, Engineering and Planners.

You will contribute to continuous improvement, apply HPLC/Empower experience, and uphold high quality standards in a fast-paced biopharmaceutical environment at Waterford campus.