(Senior) QA Qualification Specialist 80-100% (f/m/d)
Core
Ensuring qualification of facilities, utilities, equipment, and systems for new projects in the pharmaceutical industry.
Role type
Senior QA Qualification Specialist
Builds
Qualified facilities and systems for pharmaceutical manufacturing
Domain
Pharmaceutical industry / Quality Assurance / GMP
Deliverable
client delivery
Required skills
Engineering/Chemistry/Biotechnology degree, Pharmaceutical industry experience, cGMP regulations knowledge, Project execution oversight, Technical change assessment, CAPA and deviation management, Regulatory inspection representation, Fluent German
Preferred skills
English language skills, FMEA knowledge
Technologies
URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, FMEA
Responsibilities
Represent QA Qualification in project organization for new facilities, Coordinate QA interests during project phases, Drive implementation of new qualification strategy, Compile and release Qualification Documents, Perform assessments of technical change requests, Represent qualification topics during customer audits and regulatory inspections, Drive CAPA and Effectiveness Checks to completion
Seniority
Senior, hands-on IC
