QC Analyst

Sanofi Inc.; Saffron Walden; On-site; GBP 47,000 - 64,000; Full time

Job summary

Sanofi Waterford QC Analyst role seeks an analytical chemist to provide chemistries support for diverse manufacturing operations. You will interact with QA, Production, Engineering and Planners to ensure smooth batch releases and robust methods in line with cGLP.

You will train analysts, update SOPs and specifications, and contribute to continuous improvement initiatives while maintaining documentation and regulatory compliance across the site.

Qualifications

• Degree in Science (Chemistry or Biochemistry preferred).
• Post-graduate studies to augment primary degree.
• Operational experience of quality laboratories in a fast-moving manufacturing environment.
• Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, cGLP and pharmacopoeial methods.
• 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.
• Interact with other departments on materials, intermediates and finished batch releases.
• Maintain contact with QA, Production, Engineering and Planners.
• Update chemical methods, specifications and SOPs to comply with pharmacopoeial and regulatory requirements.
• Assist with training of analysts in areas of expertise and new methods.
• Trend results, record on COAs, and investigate OOS promptly.
• Update QC Team Leader on potential problems and improvements.
• Ensure testing and related equipment meet current validation (IQ/OQ/PQ).
• Audit and review chemistry results daily and ensure quality documentation is complete.
• Support new product introduction projects.

Skills

Analytical thinking

Quality mindset

Regulatory understanding

Project management

Communication

HPLC/Empower experience

Education

Bachelor's degree in Chemistry or Biochemistry

Post-graduate studies

Tools

Empower software

Job description

QC AnalystContract- Fixed Term - Full Time Location: Waterford

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

About Waterford

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to an world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.

About the job

You will contribute to the continued success of our QC department by providing analytical services to support our diverse manufacturing operations.Engage with our Continuous Improvement programme to share your ideas and experience to further optimise our laboratory function.Comply with all regulatory and safety guidelines to protect yourself, your colleagues.

Main responsibilities

• and our patients. Main 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 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.

About you

• 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.

Company values

Pursue Progress. Discover Extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!