Visual Inspection Program Lead/SME (Contract)

ProPharma; United States; Hybrid; USD 33,062,000 - 49,594,000; Full time

Job summary

ProPharma seeks a Program Lead to drive the Visual Inspection Program Enhancement workstream for a 16-week engagement. You will apply extensive experience in visual inspection, particulate-control programs, defect classification, inspection qualification, and sterile injectables to lead assessments and deliver actionable recommendations.

The role focuses on strengthening the program through risk-based enhancements to procedures, qualification methodologies, defect management practices, and

Qualifications

• 7 years of relevant experience is required for the role.

Responsibilities

• Lead all assessment activities for the Visual Inspection Program Enhancement workstream.
• Develop recommendations and prepare the associated deliverables.
• Strengthen the overall visual inspection program through risk-based enhancements to procedures and QA documentation.

Skills

Visual inspection

Defect classification

AQL

Knapp studies

Inspector qualification

Sterile injectables

Job description

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.

• Visual inspection
• Defect classification
• AQL
• Knapp studies
• Inspector qualification
• Sterile injectables

7 years of relevant experience.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

• Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager.

All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.