QC Analyst: Flexible Pharma Lab in Waterford

Sanofi Inc.; Swindon; On-site; GBP 32,000 - 44,000; Full time

Job summary

Sanofi Waterford QC Analyst is a fixed-term full-time role within a state-of-the-art biopharmaceutical campus. You will provide analytical services to support diverse manufacturing operations, engaging with CI programs to improve laboratory functions while complying with regulatory and safety guidelines.

You will work with QA, Production, Engineering and Planners, maintain methods and SOPs, train analysts, trend data, and contribute to investigations and new product introductions, all while

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 COAs 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

Quality Assurance

Regulatory compliance

Project management

Lab teamwork

Education

Degree in Science (Chemistry or Biochemistry preferred)

Post-graduate studies

Tools

HPLC

Empower

Job description

Sanofi Waterford QC Analyst is a fixed-term full-time role within a state-of-the-art biopharmaceutical campus. You will provide analytical services to support diverse manufacturing operations, engaging with CI programs to improve laboratory functions while complying with regulatory and safety guidelines.

You will work with QA, Production, Engineering and Planners, maintain methods and SOPs, train analysts, trend data, and contribute to investigations and new product introductions, all while