Expert in team leadership, planning and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.
Production management
RM tracking
Coordination with service department for smooth production
R&D developed product transfer
cGMP documentation
Process safety management
HAZOP study
Production management
cGMP documentation as per ICH Q7
Equipment qualification
Process Validation
Deviation Investigation
Phase-2 Investigation of OOS & OOT
CAPA & its Effectiveness Monitoring
QRM as per ICH Q9
Regulatory Audit handling
BMR preparation
SOP preparation
Qualification & Validation protocol preparation
Safety compliance & HAZOP study
Lab Batch observation and its Scale up as per cGMP criteria
BMR preparation
Process validation Protocol & report preparation
Investigation of deviation, OOS & OOT
Production operations monitoring
Shift handling
RM tracking
cGMP documentation
Equipment qualification
Process validation
BMR & SOP preparation
Scale up of R&D developed product
Regulatory audit facing
Coordination with service department
Safety compliances
Planning and its execution
Cost reduction
Manpower handling