QC Analyst (Data Reviewer)

Sanofi; Munster; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

Sanofi in Ireland is seeking a QC Analyst (Data Reviewer) on a 23-month fixed-term contract. The role focuses on analytical testing, data review, and ensuring compliance with cGMP and safety standards within the QC Operations group.

The candidate will perform data integrity tasks, participate in investigations, and maintain laboratory instruments and documentation to support quality products.

Qualifications

• BSc in Chemistry, Biochemistry, or a related science discipline.
• Experience with cGMP and laboratory safety requirements.
• Analytical testing and data review capabilities.
• In depth understanding of data integrity principles and good documentation practices.

Responsabilités

• Execute analytical testing in a timely manner per scheduled plans.
• Perform QC data review of tests and ensure data integrity.
• Ensure training and qualification for assigned analytical methods.
• Inform management of quality or HSE events in a timely manner and support investigations.
• Maintain lab facilities and instruments in quality and safety status.

Connaissances

cGMP knowledge

Data review

Laboratory safety

Analytical testing

Data integrity

Formation

BSc in Chemistry/Biochemistry or related science

Outils

HPLC/UPLC

CE

KF

HIAC

ELISA

FTIR

Description du poste

Job Title: QC Analyst (Data Reviewer)

FTC - 23 month fixed term contract

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

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plan
• Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.
• 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

Education

BSc in Chemistry, Biochemistry, or a related science discipline

Experience

Background in an analytical chemistry laboratory environment

• 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, KF, HIAC, ELISA, FTIR
• 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

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.

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