Quality Control Analyst / Data Reviewer

Biopharma Careers; Waterford; On-site; EUR 48,000 - 64,000; Full time

Job summary

Sanofi in Waterford, Ireland is seeking a Quality Control Analyst (Data Reviewer) to perform timely data review and ensure cGMP compliance for multiple sample types. Role involves verifying raw data, contributing to investigations, and maintaining rigorous documentation in a cgmp environment.

The position requires a BSc in chemistry/biochemistry with hands-on experience in analytical labs, proficiency in HPLC/UPLC and data integrity practices, and strong communication for cross-functional

Qualifications

• BSc in Chemistry, Biochemistry, or related science discipline.
• Experience in analytical chemistry laboratory environment.
• In-depth understanding of data integrity and good documentation practices.
• Experience with Biologics and/or HPLC/UPLC, CE, ICE techniques.

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 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.

Skills

cGMP knowledge

Data integrity

Analytical testing

HPLC/UPLC

CE techniques

ICE techniques

Data review

Documentation

Communication

Teamwork

Education

BSc in Chemistry/Biochemistry

Tools

HPLC/UPLC systems

Instrument qualification

Job description

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

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.

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 !

#LI-EUR

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.

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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€48000,00 - €64000 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.