Visual Inspection Program Lead/SME (Contract)

ProPharma Group; New York (NY); Sur place; USD 120 000 - 190 000; Plein temps

Résumé du poste

ProPharma Group seeks an experienced Visual Inspection Program Lead to direct a 16-week enhancement initiative focused on sterile manufacturing operations. You will lead assessments, develop risk-based recommendations, and deliver quality-system documentation to strengthen visual inspection procedures and defect management practices.

The role requires leading cross-functional teams, developing improvements to inspection qualification methodologies, and ensuring regulatory compliance within

Qualifications

• 7+ years of experience in visual inspection and sterile injectable operations.
• Demonstrated expertise in defect classification and AQL standards.
• Knowledge of inspector qualification methodologies and Knapp studies.
• Experience with particulate-control programs and defect management.
• Proficiency in quality-system documentation and regulatory compliance.

Responsabilités

• Lead all assessment activities across the visual inspection program enhancement workstream.
• Develop risk-based recommendations for procedures, qualification methods, and defect management.
• Prepare deliverables supporting program strengthening initiatives.
• Design and implement enhancements to inspection qualification methodologies.
• Evaluate and document quality-system improvements for sterile manufacturing.

Connaissances

Visual inspection

Sterile injectable operations

Defect classification

AQL standards

Inspector qualification methodologies

Knapp studies

Particulate-control programs

Defect management

Quality-system documentation

Regulatory compliance

Description du poste

ProPharma Group seeks an experienced Visual Inspection Program Lead to direct a 16-week enhancement initiative focused on sterile manufacturing operations. The role involves leading assessments, developing risk-based recommendations, and delivering quality-system documentation to strengthen visual inspection procedures and defect management practices.

Responsibilities

• Lead all assessment activities across the visual inspection program enhancement workstream
• Develop risk-based recommendations for procedures, qualification methods, and defect management
• Prepare deliverables supporting program strengthening initiatives
• Design and implement enhancements to inspection qualification methodologies
• Evaluate and document quality-system improvements for sterile manufacturing

Requirements

• 7+ years of experience in visual inspection and sterile injectable operations
• Demonstrated expertise in defect classification and AQL standards
• Knowledge of inspector qualification methodologies and Knapp studies
• Experience with particulate-control programs and defect management
• Proficiency in quality-system documentation and regulatory compliance