Visual Inspection Program Lead/SME (Contract)

PPG US ProPharma Group, LLC; Nevada (IA); Híbrido; USD 78.000 - 105.000; Jornada completa

Descripción de la vacante

ProPharma is seeking a Program Lead to drive the Visual Inspection Program Enhancement initiative. The role focuses on assessment, recommendations, and deliverables to strengthen the visual inspection program, including risk-based enhancements to procedures and defect-management practices.

The ideal candidate brings extensive experience in sterile injectables, defect classification, and regulatory-aligned quality systems, with at least seven years in related roles.

Formación

• Visual inspection experience required.
• Defect classification and AQL knowledge essential.
• Knapp studies familiarity preferred.
• Inspector qualification experience beneficial.
• Sterile injectables background advantageous.
• Minimum 7 years of relevant experience.

Responsabilidades

• Lead all assessment activities for the Visual Inspection Program Enhancement workstream.
• Develop recommendations and prepare deliverables to strengthen the program.
• Enhance procedures, qualification methodologies, defect management, and quality-system documentation.

Conocimientos

Visual inspection

Defect classification

AQL

Knapp studies

Inspector qualification

Sterile injectables

7 years of relevant experience

Descripción del empleo

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.

Required Experience

• Visual inspection
• Defect classification
• AQL
• Knapp studies
• Inspector qualification
• Sterile injectables
• 7 years of relevant experience
• #LI-EB3

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. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

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.