QC Analyst – Analytical Chemistry (Flexible Working)

Sanofi Inc.; Gloucester; On-site; GBP 36,000 - 49,000; Full time

Job summary

SanofiWaterford seeks a QC Analyst for a fixed-term full-time role to support analytical services across manufacturing operations. The candidate will engage with continuous improvement and ensure adherence to cGLP, pharmacopoeial methods and regulatory guidelines.

Strong HPLC/Empower experience and quality laboratory background are essential. You will collaborate with Quality Assurance, Production, Engineering and Planners, maintaining methods and SOPs while training analysts and contributing to

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.
• Close contact 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

Quality control

Regulatory compliance

Education

Bachelor’s degree in Chemistry/Biochemistry

Post-graduate studies

Job description

SanofiWaterford seeks a QC Analyst for a fixed-term full-time role to support analytical services across manufacturing operations. The candidate will engage with continuous improvement and ensure adherence to cGLP, pharmacopoeial methods and regulatory guidelines.

Strong HPLC/Empower experience and quality laboratory background are essential. You will collaborate with Quality Assurance, Production, Engineering and Planners, maintaining methods and SOPs while training analysts and contributing to