Good knowledge about current regulatory requirements and extensive experience in performing internal audits and ensuring the compliance.
Working experience for review and audit submission documents along with supporting data related to R&D, Production, Quality control and Regulatory Affairs.
Good working experience in handling OOS, OOT, Incidents and CAPA related to analysis.
Extensive experience in Analysis and Review of raw materials, finished products and stability samples.
Good working knowledge of software like Empower, Tiamo, SDMS, LIMS, QMS, DMS, TRIMS, LDRO etc.
Experience in Performing and Monitoring GMP activities.
Extensive experience in preparation of schedules, ...