QC Analyst

Sanofi Inc.; Cheltenham; On-site; GBP 34,000 - 47,000; Full time

Job summary

Sanofi Waterford seeks a QC Analyst to provide analytical chemistry support for manufacturing operations. You will engage with continuous improvement to optimise laboratory functions and ensure compliance with pharmacopoeial and regulatory standards.

The role requires a science degree (chemistry or biochemistry), plus at least two years HPLC/Empower experience and strong quality laboratory exposure. Training and collaboration across QA, Production and Engineering are expected.

Qualifications

• Degree in Science (Chemistry or Biochemistry) required.
• Post-graduate studies may augment degree.
• Operational experience in quality laboratories in a fast-moving manufacturing environment.
• Knowledge of cGLP and pharmacopoeial methods.

Responsibilities

• Provide analytical chemistry services to support Site manufacturing operations.
• Maintain, update and issue chemical methods, specifications and SOPs in line with regulatory requirements.
• Assist with training of analysts in areas of expertise and new methods, SOPs and updates.
• Trend results, record on COAs, and complete OOS investigations timely.
• Audit and review chemistry test results daily and ensure cGLP compliance.
• Support new product introduction projects.

Skills

HPLC/Empower

Quality labs experience

Regulatory awareness

Education

Degree in Science (Chemistry or Biochemistry preferred)

Post-graduate studies

Tools

Empower

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!