Product Lifecycle Specialist
Core
Oversight of the product lifecycle for the manufacturing site, including Periodic Product Review (PPR), change controls, stability programs, and complaint management.
Role type
Quality Specialist (Product Lifecycle)
Builds
Compliance reports and quality assessments for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Periodic Product Review (PPR) execution, change control management, stability program oversight, CAPA management, data trending, GMP compliance, Veeva QMS proficiency, SAP data retrieval
Preferred skills
Technical knowledge of pharmaceutical disciplines, project reporting, cross-functional collaboration
Technologies
Veeva QMS, Veeva QDocs, SAP
Responsibilities
Compile PPRs per annual schedules, retrieve data from VQMS and SAP for investigations and batch analysis, perform peer reviews of PPRs, identify out-of-trend issues and facilitate resolution, raise deviations and CAPAs, maintain and archive PPR documentation
Seniority
Mid-Senior, hands-on IC
