Position Overview
QA System
PURPOSE
As core function for Bayer Cimanggis plant unit on assuring the compliance of Bayer and authority regulations related with GxP, Computerized System Validation (CSV), Qualifications activities, and managing the technical system and computerized system life cycle (including calibration) which consists of but not limited to Commissioning-Decommissioning activities.
MAJOR TASKS & RESPONSIBILITIES
Ensure the Technical System lifecycle is implemented according to the updated SOP by performing qualification of technical system and maintain its requalification status.Conduct the review of the technical system lifecycle document consists of B-review, Quality Impact Assessment, URS, Functional Specification, Risk Assessment, Commissioning Document (GMP Relevant), Qualification Document.Coordinating with the technical system owner and project lead according to technical system life cycle activities.<...