QA Aseptic Project

As part of the Quality Stream Aseptic Project structure and reporting directly to the Quality Stream Lead, the QA Aseptic Project will be responsible for supporting decision-making processes related to quality requirements during the design phases of Dispensing, Compounding, Filling (isolator), and auxiliary equipment for the project (Grade C environment).

Tasks and responsibilities

• Support decision-making regarding quality requirements during the design phases of Dispensing, Compounding, Filling, and auxiliary equipment for the aseptic project.
• Participate in the drafting, review, or approval of documents resulting from decisions made during the project design phases (e.g., rationales, risk analyses).
• Review and approve documents related to the qualification-validation lifecycle of production equipment, process and cleaning validations, laboratory equipment, computerized systems, analytical method validations and transfers, utilities, and ...