Visual Inspection Program Lead/SME (Contract)

ProPharma • Raleigh, NC

3d • Hybrid

About The Position

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Duration: approx. 16 weeks (400 hours)

Scope:
To support execution of the Visual Inspection Program Enhancement workstream, requiring a dedicated Program Lead with extensive experience in:
Visual inspection
Particulate-control programs
Defect classification
Inspection qualification
Sterile manufacturing operations

This individual will lead all assessment activities, develop recommendations, and prepare the associated deliverables supporting this workstream.

The objective is to strengthen the overall visual inspection program through risk-based enhancements to procedures, qualification methodologies, defect management practices, and supporting quality-system documentation.

Requirements

• Visual inspection experience
• Defect classification experience
• AQL experience
• Knapp studies experience
• Inspector qualification experience
• Sterile injectables experience
• 7 years of relevant experience

Nice To Haves

• Extensive experience in Visual inspection
• Extensive experience in Particulate-control programs
• Extensive experience in Defect classification
• Extensive experience in Inspection qualification
• Extensive experience in Sterile manufacturing operations

Responsibilities

• Lead all assessment activities for the Visual Inspection Program Enhancement workstream.
• Develop recommendations for strengthening the visual inspection program.
• Prepare associated deliverables supporting the workstream.
• Enhance procedures, qualification methodologies, defect management practices, and supporting quality-system documentation through risk-based approaches.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed