Vignesh Saravanan

Dedicated pharmaceutical quality and manufacturing professional with a proven track record of meeting company goals through consistent and organized practices. Experienced in working under pressure and adept at adapting to new situations and challenges to enhance the organizational brand.

• Review of critical investigation reports including OOS & OOT and scoring of investigation reports and providing insights to sites about improvement areas.
• Incident analysis was done for few sites to identify any trend and sharing the observations to site to create an action plan to reduce the number of incidents.
• Providing training to sites on Culture transformation activities, GEMBA walk and Stratification of incidents.
• Project on 'Stratification & Analysis of incidents' was successfully done to reduce the number of incidents by identifying the top contributing incidents.
• Project on repeat 'OOS investigation' of stability was done for one site to identify the root cause & to propose CAPA which added a value to my experience & knowledge through which my learning about the process got improved.
• Project on 'Procedure vs Practice' was done to identify the gaps which provided the sites to have an external view on their gaps & improvement areas.