GDP Compliance Specialist - Manufacturing Quality

Sanofi Group; Pearl River (NY); On-site; USD 59,000 - 85,000; Full time

Benefits offered by this job

Health and wellbeing benefits

Paid parental leave

Rewards package

Job summary

Sanofi Pearl River, NY is seeking a Manufacturing GDP Specialist responsible for ensuring GDP-compliant documentation by reviewing batch records and logbooks, coaching shopfloor staff, and correlating corrections with regulatory requirements. You will partner with Manufacturing Technicians to safeguard product quality and regulatory compliance across manufacturing operations.

The role emphasizes error tracking, CAPA support, deviation investigations, and collaboration with Quality and

Qualifications

• GDP knowledge and regulatory compliance
• Batch record and logbook review
• Error tracking and continuous improvement
• CAPA and deviation investigation support
• Cross-functional collaboration with Manufacturing & Quality
• Strong documentation and attention to detail

Responsibilities

• Track and review manufacturing batch records and logbooks to ensure GDP/regulatory compliance
• Cooperate with Manufacturing Technicians to implement timely corrections
• Maintain error-tracking metrics and identify recurring GDP violations
• Participate in deviation investigations and CAPA creation
• Support regulatory inspections and internal audits of documentation practices
• Collaborate with Quality, Manufacturing, and shopfloor teams to reinforce GDP adherence

Job description

Sanofi Pearl River, NY is seeking a Manufacturing GDP Specialist responsible for ensuring GDP-compliant documentation by reviewing batch records and logbooks, coaching shopfloor staff, and correlating corrections with regulatory requirements. You will partner with Manufacturing Technicians to safeguard product quality and regulatory compliance across manufacturing operations.

The role emphasizes error tracking, CAPA support, deviation investigations, and collaboration with Quality and