Developing Quality system (Green field project)

Redefining the way and culture... To develop sustainable quality system. Responsible for management of overall quality system at site and also ensuring the quality KPIs. Ensuring all investigation (laboratory and manufacturing) are well investigated and closed in timely manner also to make sure control strategy implemented on time. Inspection management (hosting audit to responding observation and CAPA implementation). To ensure vendor development via life cycle approach. Batch disposition to distribution of drug substance- Making sure it is done with the high degree of compliance. Complaint management. Statistical and trending of various QMS (Complaint, deviation, human error etc)Initiation and Implementation of quality improvement plans. Ensuring customer requests responded well on time and providing site support to respond regulatory queries. Part of team to embrace the quality culture.

Bringing the change and way to effectively management of QMS. The major part of QMS handled was change control and deviation management, Auditing, vendor development and lifecycle management. Develop and determine site audit readiness....accordingly ensuring QMS documentation is ready for the inspection.

Developed quality requirement, specifically in API analytical section. Implementation of various procedure, controlled system, ensuring validation of various analytical instrument and software's Reviewing process and analytical method development reports. Also verifying MV activities. Handing corporate audits and ensuring compliance.

Responsible for Change control, Process validation and cleaning validation. Also supporting in technology transfer. Verifies processes and the relevant workers’ qualifications. Orderly collect and manage documents certifying tests, controls and inspections carried out witnessing the tests, controls and inspections carried out. Manage selected projects (at that time few projects were transferring from Germany), quality and timeframe targets. Build networks within the various department. Ensuring manufactured products meet set standards of quality, reliability and performance (like making sure before disposition of batch(s) relevant QMS activities closed).

Responsible for manufacturing related activities (like batch charging, isolation, drying etc and other activities related to water unit and utilities).