Quality Assurance Manager* (m/w/d) Qualifizierung/Validierung
Core
Manage GMP-compliant Quality Management System (QMS), develop processes and standards, and oversee qualification and validation activities for facilities, equipment, utilities, and computerized systems in a life science/pharmaceutical context.
Role type
Quality Assurance Manager (GMP Qualification & Validation)
Builds
Qualified and validated manufacturing environments, equipment, and computerized systems for life science applications.
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Required skills
GMP compliance, Risk Management (ICH Q9), Validation protocols (DQ/IQ/OQ/PQ), CAPA management, Technical change control, FAT/SAT participation, Interdisciplinary project management, IT proficiency (MS Office)
Preferred skills
Pharmaceutical production or analytics experience, Chemical/Biochemical/Microbiology analytics knowledge
Technologies
GAMP 5, Annex 11, Annex 15, 21 CFR Part 11, ICH Q9
Responsibilities
Review and approve URS, risk analyses, and qualification/validation documentation; Ensure GMP-compliant qualification of systems and utilities; Provide QA oversight for validation and monitoring activities; Evaluate deviations, root causes, and trends; Assess technical changes and support risk-based qualification strategies; Represent QA in engineering projects and commissioning.
Seniority
Mid-Senior, hands-on IC