Quality Control Analytical Expert

Biopharma Careers; Waterford; Hybrid; EUR 55,000 - 73,000; Full time

Job summary

Sanofi in Waterford, Ireland is seeking a Quality Control Analytical Expert for a 12-month fixed term, hybrid work model (3 days on-site, 2 days remote). The role involves analytical support for method validation, transfers, troubleshooting, and investigations within a cGMP environment.

You’ll work with cross-functional teams to drive analytical excellence and continuous improvement, contributing to Sanofi’s manufacturing and supply network globally.

Qualifications

• Significant experience in quality control within the pharmaceutical industry.
• Knowledge of GMP and regulatory requirements.
• Ability to analyze complex data and make informed decisions.
• Detail-oriented with accuracy in testing and reporting.

Responsibilities

• Providing analytical expertise for projects, troubleshooting and investigations on analytical methods and lab technologies.
• Coordinating analytical testing on projects (validation/transfer), ensuring adherence to schedules.
• Performing tasks in compliance with cGMP and HSE requirements and related instructions.
• Recording raw data, calculations, and information to comply with 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 manager of any quality or HSE events in a timely manner for investigations.
• Participating in investigations to ensure investigations and impact assessment are performed appropriately.
• Performing periodic trend analysis on method performance to determine need to revalidate, optimize, or replace the method.
• Ensuring that lab/facilities and instruments are kept in quality and safety status.
• Supporting QC teams during internal and external audits and inspections.

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.

Join a global network that powers how Sanofi delivers, seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

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.

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 :€54800,00 - €73067 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.