Quality Control Analytical Expert

Sanofi; Waterford; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Sanofi in Waterford is seeking a Quality Control Analytical Expert to provide analytical expertise across method validation, transfers, troubleshooting, and investigations, in line with cGMP, quality and safety standards.

You will collaborate with cross-functional teams to drive analytical excellence and support continuous improvement across QC operations, with hybrid working arrangement (3 days on-site, 2 days remote).

Qualifications

• Significant experience in quality control within the pharmaceutical industry, including knowledge of GMP and regulatory requirements.
• Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification.
• Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement.
• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.

Responsibilities

• Providing analytical expertise for projects, troubleshooting, investigation on analytical methods and lab technologies
• Coordinate analytical testing on projects (validation/transfer), ensuring adherence to the committed scheduled plans
• Performing 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 tasks, to comply with cGMP and data integrity requirements
• Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities
• Writing/reviewing and maintaining accurate analytical methods procedures
• Informing the manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment
• Participating actively to any investigation, where involved, to ensure investigations and impact assessment are performed appropriately
• Performing periodically trend analysis on method performance to determine the need to revalidate, optimize, or replace the method
• Ensuring that lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately
• Supporting QC teams during internal and external audits and inspections

Skills

Quality control

GMP compliance

Data analysis

Analytical chemistry

Education

Degree in science or related discipline

Job description

Job Title: Quality Control Analytical Expert

• Location: Waterford, Ireland




• Working Arrangement: Hybrid - 3 Days On-Site, 2 Days Working From Home Remotely




• Job type: Full-Time, 12-Month Fixed Term Contract

About the job

As a Quality Control Analytical Expert, you'll provide analytical expertise to support method validation, transfers, troubleshooting, and investigations, while ensuring compliance with cGMP, quality, and safety standards. You'll work closely with cross-functional teams to drive analytical excellence and support continuous improvement across QC operations.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Providing his/her analytical expertise for any project, troubleshooting, investigation on analytical methods and lab technologies


• Coordinate analytical testing on projects (validation/transfer), 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


• Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities


• Writing/reviewing and maintaining accurate analytical methods procedures


• 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


• Performing periodically trend analysis on method performance to determine the need to revalidate, optimize, or replace the method


• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately


• Supporting QC teams during internal and external audits and inspections

About you

• Significant experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.


• Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification.


• Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement.


• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.


• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.


• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.


• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.


• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.