QC Analyst — Flexible Working, Biopharma Lab

Sanofi Inc.; Plymouth; On-site; GBP 36,000 - 53,000; Full time

Job summary

Sanofi Waterford is seeking 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 share ideas to optimise the laboratory function while complying with regulatory and safety guidelines.

The role requires a degree in science (chemistry or biochemistry), at least two years' HPLC/Empower experience, and strong knowledge of quality management systems, cGLP and

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 SOP's in compliance to pharmacopoeial and regulatory requirements.
• Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's 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 equipmentmeets 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 experience

Quality laboratory experience

Analytical chemistry

Regulatory/compliance knowledge

Project management

Education

Degree in Science (Chemistry or Biochemistry)

Post-graduate studies

Job description

Sanofi Waterford is seeking 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 share ideas to optimise the laboratory function while complying with regulatory and safety guidelines.

The role requires a degree in science (chemistry or biochemistry), at least two years' HPLC/Empower experience, and strong knowledge of quality management systems, cGLP and