Quality Assurance in Production
Zentiva · Bucharest, București, RO
Responsibilities: 1. Management of deviations: a. Ensures the initiation and investigation of deviations in accordance with the procedures in force in the TW...
Job description
Responsibilities: 1. Management of deviations: a. Ensures the initiation and investigation of deviations in accordance with the procedures in force in the TW system b. Is the leader of the local investigation team c. Ensures that the investigation steps assigned to the specialists in the respective area and the conclusions leading to the identification of the root cause are completed on time. d. Evaluates the CAPA plan and ensures that it addresses the elimination of the root cause and eventual recurrence of the event e. Permanently maintains contact with QA specialists and qualified persons (as applicable) so that all steps taken are known and agreed upon in a timely manner 2. Complaints management: a. Is the leader of the local investigation team b. It is ensured that the investigative steps assigned to the specialists in the respective area and the conclusions leading to the identification of the root cause are completed on time. c. Evaluates the CAPA plan and ensures that it addresses the elimination of the cause and eventual recurrence of the event 3. Change control management: a. Monitors change requests in the TW system b. Assumes the role of change responsible and coordinat...