QC Analyst

Sanofi EU; Munster; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Onsite gym

Medical centre

Flexible working

Job summary

Sanofi Waterford is seeking a QC Analyst to contribute to analytical services across diverse manufacturing operations. You will work within a fast-paced quality environment, supporting regulatory compliance and continuous improvement.

The role requires a science degree and hands-on experience with HPLC/Empower, with responsibilities including method updates, data trend analyses, and collaboration with QA, Engineering and Production. A commitment to quality and patient safety is essential.

Qualifications

• A Degree in Science, preferably Chemistry or Biochemistry.
• Operational experience in quality laboratories within a fast-moving manufacturing environment.
• Detail knowledge of quality management systems, pharmacopoeial methods and stability.
• Understanding of quality/compliance regulations.
• Ability to manage projects to plan and budget.
• Minimum two years HPLC/Empower experience.

Responsibilities

• Provide analytical chemistry services and support to Site.
• Interact with QA, Production, Engineering and Planners on materials and batch releases.
• Maintain, update and issue chemical methods, specifications and SOPs in compliance with pharmacopoeial and regulatory requirements.
• Assist with training of the analysts in expertise areas and new methods, SOPs and updates.
• Trend such results, record on COAs where required and complete OOS investigations timely.
• Update the QC Team Leader on potential problems and highlight improvements by normal communication channels.
• Ensure critical chemical testing and related equipment meet current validation requirements (IQ, OQ, PQ).
• Audit and review chemistry test results daily and ensure compliance with cGLP.
• Ensure all quality documentation and records are complete and current.
• Support new product introduction projects.

Skills

HPLC

Empower

Quality labs experience

Regulatory knowledge

Education

Bachelor's in Chemistry/Biochemistry

Tools

SOPs management

Job description

• 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 .

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