i-Pharm GxP ยท 3 weeks ago
Raw Material Qualification Lead
i-Pharm GxP is an established global life sciences manufacturer expanding operations at its GMP site in Lebanon, Indiana. They are seeking a Raw Material Qualification Lead to manage the raw material qualification process, lead supplier qualification activities, and ensure compliance with quality systems.
Responsibilities
Own the end to end raw material qualification process for GMP manufacturing
Lead supplier qualification activities including risk assessments and material approvals
Develop and execute raw material qualification strategies for new and existing products
Author and review controlled documentation supporting material lifecycle management
Support investigations deviations and change controls related to raw materials
Act as the quality point of contact for material related topics across site functions
Qualification
Required
Background in raw material qualification within pharmaceutical or biologics manufacturing
Strong understanding of GMP quality systems and regulatory expectations
Experience working with suppliers and cross functional site teams
Proven ability to lead material qualification activities independently
Strong written documentation and stakeholder communication skills
Company
i-Pharm GxP
Consulting Services to scope, staff, manage and deliver GxP solutions across North America, Europe and the Asia-Pacific.
Funding
Current Stage
Early StageCompany data provided by crunchbase