(Senior) QA Experte (m/w/d).

Job ID: 10893

Jetzt bewerben
Discipline
Quality/Production
Type of employment
Project Consulting
Responsibilities
  • Updating the existing QM system according GMP compliance
  • Creation, review and approval of manufacturing and testing protocols, superordinate SOPs and validation documents
  • Editing changes and deviations (CAPA, Change Control, Batch Record Review)
  • Preparation of plans, protocols, for all qualification, validation (analytics, equipment, plants, process)
  • Creation and evaluation of risk analyzes for process validations
  • Contact for production and laboratory staff regarding equipment, equipment qualification and method validation
Requirements
  • Minimum B.Sc in biochemistry, pharmacy, biology or equivalent
  • 4+ years of professional experience in cGMP regulated biopharma industry, preferably with in depth experience in Quality & Compliance
  • Broad practical routine in representing Quality & Compliance in CAPEX projects from planning to successful health authority inspections.
  • Knowledge of international laws, regulations and requirements for the production of active ingredients (biologics focus), US / EU GxP regulations
  • Strong decision making, analytical skills and the ability to manage multiple projects at the same time
  • Fluent communication skills both in english and german
Region
Mitte