Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not Disclosed
- Location
- Waterford
- Employment
- Contract
- Experience
- Minimum two years HPLC/Empower experience.
- Education
- Degree in Science (Chemistry or Biochemistry preferred).
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Role Summary
The QC Analyst provides analytical chemistry services to support manufacturing operations and contributes to the QC department’s continuous improvement work. The role supports quality testing, documentation, compliance, and new product introduction.
What You'll Do
- Provide analytical chemistry services and support to the site.
- Interact with other departments on raw materials, intermediates, and finished batch releases.
- Maintain, update, and issue chemical methods, specifications, and SOPs.
- Assist with analyst training in areas of expertise and on new or updated methods and SOPs.
- Trend results, record them on COAs where required, and complete OOS investigations.
- Ensure critical chemical testing and related equipment meet validation requirements; audit chemistry test results and maintain complete,...
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Degree in Science; operational experience in quality laboratories in a fast-moving manufacturing environment; detailed knowledge of quality management systems, pharmaceutical manufacturing operations, cGLP, pharmacopoeial methods and stability; understanding of relevant quality/compliance regulations; ability to manage projects to plan and budget; minimum two years HPLC/Empower experience.
Required
- Degree in Science.
- 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...
- Understand relevant quality/compliance regulations.
- Can manage projects to plan/budget.
- Minimum two years HPLC/Empower experience.
Preferred
- Chemistry or Biochemistry degree subject.
- Post-graduate studies as appropriate to augment primary degree.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
- QC Analyst
- Contract- Fixed Term - Full Time
- Location: Waterford
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 a 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 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.
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.
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.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€41.600,00 - €62.400,00Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
About the company
Sanofi
Large Enterprise
Sanofi is a global healthcare leader committed to promoting health and well-being through the development of innovative medicines, vaccines, and therapeutic solutions. With a diverse portfolio that spans multiple therapeutic areas, including diabetes, oncology, and immunology, Sanofi is dedicated to addressing pressing health challenges and improving patient outcomes worldwide. Headquartered in France, the company employs over 100,000 individuals across more than 100 countries, fostering a culture of collaboration and scientific excellence to drive advancements in healthcare.