Quality Control Analyst / Data Reviewer

About the Role

This position involves working at Sanofi's Waterford, Ireland location for a fixed term of 23 months, focusing on data review and quality control within cGMP regulated environments.

Team Overview

The Quality Control team manages the receipt and testing of various production samples and environmental samples, ensuring all product standards meet CGMP requirements. Responsibilities extend to raw material and stability testing, assay transfers, and equipment qualification. The group also supports laboratory and deviation investigations, CAPA programs, training initiatives, change controls, and validation efforts related to methods and equipment. Participation in site-wide projects and studies is expected.

Key Responsibilities

• Conduct timely and thorough data review adhering strictly to agreed schedules.
• Carry out tasks following cGMP, Health, Safety, and Environment (HSE) standards, adhering to all related standard operating procedures and documentation.
• Verify all raw data, computations, and details ensuring full compliance with cGMP and data integrity protocols.
• Maintain qualification and training in assigned analytical methods.
• Promptly report quality or HSE incidents, such as deviations and out-of-specification findings, for appropriate investigation and impact evaluation.
• Assist in investigations to guarantee comprehensive analysis and accurate impact assessment.
• Ensure laboratory instruments and facilities are maintained in compliance with quality and safety standards to support correct usage.

Candidate Profile

• Possess a BSc degree in Chemistry, Biochemistry, or a related scientific discipline.
• Experience working within an analytical chemistry laboratory setting.
• Familiarity with cGMP protocols and laboratory safety regulations.
• Skilled in analytical testing and precise data review.
• Deep understanding of data integrity principles and excellence in documentation practices.
• Experience with biologics and analytical techniques such as HPLC/UPLC, Capillary Electrophoresis (CE), and Imaged Capillary Electrophoresis (ICE).
• Meticulous attention to detail and accuracy in documenting results.
• Strong communication abilities for clear reporting and teamwork.
• Proficient problem-solving skills applicable to investigative processes.
• Dedication to maintaining high quality and safety standards.
• Collaborative team spirit and active engagement in group activities.
• Effective task prioritization and adherence to deadlines.

Additional Information

At Sanofi, diversity, equity, and inclusion are core values. They uphold equal opportunity for all applicants regardless of gender, race, age, disability, or any other status. The company encourages potential candidates to be part of a diverse and collaborative environment aimed at scientific progress and better healthcare outcomes.