Quality Control Analyst / Data Reviewer

Sanofi; Waterford; On-site; EUR 36,000 - 48,000; Full time

Job summary

Sanofi Waterford, Ireland, is seeking a Quality Control Analyst (Data Reviewer) for a 23-month FTC to support CGMP compliant data review of analytical results.

The role covers data integrity, documentation, and investigations within Quality Control, with emphasis on HPLC/UPLC methods and Biologics exposure. A strong team focus and adherence to safety are required.

Qualifications

• BSc in Chemistry, Biochemistry, or a related science discipline.
• Experience in an analytical chemistry laboratory environment.
• Understanding of data integrity and good documentation practices.
• Experience with cGMP and laboratory safety requirements.

Responsibilities

• Perform data review in a timely manner, ensuring adherence to scheduled plans.
• Verify raw data, calculations and information to comply with cGMP and data integrity requirements.
• Follow cGMP and HSE requirements and related procedures.
• Ensure appropriate training and qualification for assigned methods.
• Inform management of quality or HSE events promptly for investigation.
• Maintain laboratory facilities and instruments in quality and safety status.

Skills

cGMP experience

Data review

Documentation accuracy

Attention to detail

Communication skills

Team collaboration

Education

BSc in Chemistry or related science

Tools

HPLC/UPLC

Biologics

CE

ICE techniques

Job description

Quality Control Analyst (Data Reviewer)

Location: Waterford, Ireland

Job Type: 23-month FTC

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About the job

Our Team

Quality Control (QC) is responsible for sample receipt, testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation.

The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site-wide studies and projects.

Main Responsibilities

• Perform data review in a timely manner, ensuring adherence to committed scheduled plans


• Perform tasks in accordance with cGMP and HSE requirements, following all associated instructions, procedures, and records


• Verify all expected raw data, calculations, and information to comply with cGMP and data integrity requirements


• Ensure appropriate training and qualification for assigned methods


• Inform management of any quality or HSE events (deviations, out-of-specification results) promptly to ensure proper investigation and impact assessment


• Support investigations to ensure thorough analysis and appropriate impact assessment


• Maintain laboratory facilities and instruments in quality and safety status to ensure appropriate use

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About you

Education: BSc in Chemistry, Biochemistry, or a related science discipline

Experience: Background in an analytical chemistry laboratory environment

Technical skills:

• Experience with cGMP and laboratory safety requirements


• Analytical testing and data review capabilities


• In depth understanding of data integrity principles and good documentation practices


• Experience with Biologics and/or HPLC/UPLC, CE, ICE techniques

Soft skills:

• Excellent attention to detail and accuracy in documentation


• Strong communication skills for reporting and collaboration


• Problem-solving abilities for investigations


• Commitment to quality and safety standards


• Team collaboration and active participation


• Demonstrated ability to prioritise tasks and adhere to agreed timelines

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Pursue Progress, discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress does not 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, color, 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!

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