Review of Change Control, Temporary Change Control, Deviation and CAPA and following up for the closer of the action plan.
Trending of QMS elements.
Effective monitoring of Quality management systems like Change Controls, Deviations, OOS, Investigations, CAPA, Trainings etc.
Ensure appropriate system for tracking and trending of Quality data and its feedback into the management review. To escalate critical events to management as and when required as per the process.
To ensure all the CAPAs and risk assessment related to client, regulatory inspections are completed on time.
Involved in the review of investigations related deviations, non-conformances, and out-of-specification results related to drug product or drug substance participating in root cause analysis and corrective action implementation.
Performed the day-to-day operations of Quality management system.
Support for implementation of digitalization project.
Maintain a thorough understanding of regulatory requirements related to drug product manufacturing, aseptic processes, and microbiology, and apply this knowledge to enhance quality assurance practices.
Effective organizational skills, able to manage multiple tasks and priorities within a dynamic environment.
To ensure integrity of data within the quality system documents.
Responsible for preparation and review of SOPs related to QA function.
