Hybrid QC Analytical Expert | cGMP & Method Validation

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

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.