Senior Quality Assurance Expert Compliance, Drug Product Services
Core
Drive supplier qualification activities for GMP-relevant materials, services, and equipment across Basel and Stein, acting as a key interface between Swiss and Indian teams.
Role type
Senior Quality Assurance Expert (Supplier Qualification)
Builds
Qualified supplier base for drug product manufacturing
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Supplier qualification & lifecycle management)
Required skills
Supplier qualification, GMP compliance, lifecycle management, documentation review, CAPA resolution, audit representation
Preferred skills
Sterile manufacturing experience, customer/regulatory audit exposure (Swissmedic, FDA), German language
Technologies
GMP documentation systems, Quality management tools
Responsibilities
Manage qualification and lifecycle of GMP-relevant suppliers, Act as primary Quality contact for supplier qualification, Review and approve supplier documentation, Drive resolution of supplier-related CAPAs and deviations, Represent Supplier Quality during customer audits and authority inspections
Seniority
Senior, hands-on IC