GDP Quality & Compliance Specialist - Manufacturing

Sanofi Group; Pearl River (NY); Presencial; USD 65.000 - 95.000; Jornada completa

Descripción de la vacante

Sanofi is seeking a Manufacturing GDP Specialist in Pearl River, NY to ensure integrity of manufacturing documentation by reviewing batch records and logbooks for GDP and regulatory compliance. You will partner with Manufacturing Technicians to drive timely corrections and support CAPA development.

This role focuses on reducing review cycle times, escalating GDP issues, and coaching shopfloor personnel on GDP principles.

Formación

• High school diploma or equivalent; 1+ year GMP manufacturing.
• Experience with GDP and cGMP regulations is preferred.
• Exposure to EBR systems and deviation investigations.

Responsabilidades

• Track and review batch records and logbooks for GDP compliance.
• Maintain error-tracking metrics and drive corrective actions.
• Escalate GDP issues affecting safety, quality, and efficacy.
• Collaborate with Manufacturing, Quality, and shopfloor teams.
• Support deviation investigations and CAPA creation.
• Support regulatory inspections and internal audits.

Conocimientos

Detail-oriented

Interpersonal skills

Team collaboration

GDP knowledge

cGMP knowledge

Problem solving

Written communication

Verbal communication

Educación

Associate degree

Bachelor's degree

Herramientas

Excel

Electronic batch records

Descripción del empleo

Sanofi is seeking a Manufacturing GDP Specialist in Pearl River, NY to ensure integrity of manufacturing documentation by reviewing batch records and logbooks for GDP and regulatory compliance. You will partner with Manufacturing Technicians to drive timely corrections and support CAPA development.

This role focuses on reducing review cycle times, escalating GDP issues, and coaching shopfloor personnel on GDP principles.