Hybrid QC Analytical Expert - 12-Month Contract

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

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).