Lead Visual Inspection Program & SME

ProPharma Group

New York (NY)

On-site

USD 120,000 - 190,000

Full time

6 days ago
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Job summary

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.

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.

Skills

Visual inspection
Sterile injectable operations
Defect classification
AQL standards
Inspector qualification methodologies
Knapp studies
Particulate-control programs
Defect management
Quality-system documentation
Regulatory compliance

Job description

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

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