Compliance Specialist *in (m/w/d)
Core
Compliance partner for Quality Control (QC) in a pharmaceutical manufacturing environment, serving as the central interface between QC, Quality Assurance, and other departments.
Role type
Compliance Specialist (Pharmaceutical Manufacturing)
Builds
Supports Quality Control operations and regulatory compliance for cancer medication production.
Domain
Pharmaceutical industry / GMP-regulated manufacturing
Deliverable
dashboards & analysis
Required skills
GMP requirements, Quality Management processes, FDA requirements, Data Integrity, Deviation management, CAPA, Risk analysis, Change controls
Preferred skills
Chemistry lab training (Chemielaborant), CTA, PTA, Natural sciences degree
Technologies
None stated
Responsibilities
Serve as central interface between QC, QA, and other departments; Coordinate and process deviations, OOS, and OOT events; Support root cause analyses and CAPA definition; Conduct and moderate risk analyses; Manage change controls related to QC; Monitor deadlines, actions, and quality KPIs; Create, review, and maintain standard operating procedures and quality documents.
Seniority
Mid-level, experienced IC