about company :
Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
Website
http://vbshilpa.com
vacancy details :
Experience: 4-8 years
Department: Quality Assurance(Clinical trials)
Job Location: Nacharam, Hyderabad
Please share your CV to karthik.kumar@vbshilpa.com
Job Description :
*Responsible for ensuring the quality and consistency of Clinical study audits and site Qualification audits of Hospitals and other Contract Research Organization for feasibility clinical studies.
*Review of Draft Clinical study reports and raising of queries if any.
*Provides training to new joiners based on the training plan.
*Documentation distribution for departmental personal and new joiners.
*Plays an active role in the preparation and conduct of internal audits.
*Plays an active role in the preparation and conduct of vendor qualification audits for external outsourced activities.
*Support to external health authority inspections.
*Accountable for tracking change control and deviations to all SOPs or impacting and escalating issues.
*Accountable for review of CAPA, maintain CAPA records and ensure the CAPA implementation.
*Collates and reviews compliance data from cross functional departments, if applicable.
*Archives documents according to prevailing standards.
*Handling of Quality Management system.
*Accountable for review or/and approval of all cross functional departments Standard Operating Procedures (SOPs).
*Responsible for documentation and monitoring of incident, deviations investigation/ event reports.
*Accountable for preparation of training program/ training log or training needs to all internal department personnel.
note :
Please share your CV to Please share your CV to karthik.kumar@vbshilpa.com