Quality Control Analyst / Data Reviewer

Sanofi; France; Sur place; EUR 48 000 - 64 000; Plein temps

Résumé du poste

Sanofi is seeking a Quality Control Analyst (Data Reviewer) in Waterford, Ireland, for a 23-month FTC. The role focuses on data review of analytical results, CGMP compliance, and strong data integrity with comprehensive documentation practices.

The candidate should hold a BSc in Chemistry or related science and have lab experience in analytical chemistry, including HPLC/UPLC, CE, and ICE techniques. Join a team supporting CGMP operations, training, investigations, and instrument qualification,

Qualifications

• Bachelor's degree in Chemistry, Biochemistry or related science
• Experience in an analytical chemistry laboratory environment
• Ability to review data and ensure data integrity

Responsabilités

• Perform data review in a timely manner, adhering to scheduled plans
• Verify raw data, calculations, and information for CGMP and data integrity
• Ensure training and qualification for assigned methods
• Inform management of quality or HSE events promptly to prompt investigation

Connaissances

Analytical data review

cGMP compliance

Data integrity

Documentation practices

Communication skills

Attention to detail

Formation

BSc in Chemistry or related science

Outils

HPLC/UPLC

CE

ICE techniques

Description du poste

Quality Control Analyst (Data Reviewer)

Location: Waterford, Ireland

Job Type: 23-month FTC

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 i nvestigations to ensure thorough analysis and appropriate impact assessment
• Maintain laboratory facilities and instruments in quality and safety status to ensure appropriate use

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 a ttention 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

Fair Pay and Equal Opportunity

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.

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.

Salary and benefits

The salary range for this position is :€48 000,00 - €64 000 Final 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.

Company vision

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.

#LI-EUR

Company vision

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.