A Professional Quality Assurance Pharmacist since 2011. Experienced in Pharmaceutical Quality system(PQS), Process & Cleaning Validation,Qualification of HVAC, PW System, Manufacturing Equipment & Utilities . Management of Internal, Regulatory & Vendor Audit. Attended GMP regulatory Audit from PIC/S participating authorities, Local Licensing authority DGDA, Independent GMP Assessment Conducted by Certified Auditors / Organization, Local and global Audit for API & Packaging Material Vendors, Successfully Conducted FAT for Major Equipment and system. Investigation of Quality defects & GMP noncompliance & implementation of CAPA. Risk based approaches in different functional areas of GxP. Evaluation of PQR & CPV for monitoring Product Quality as per Expectation. Conducting employee Training for interpretation of GMP, ICH,ISO, PIC/S Guidelines/Standards .
Gap Assessment between Current practice and Regulatory Requirement ,taking initiative to fulfill the requirements with adequate resources for Continuous Quality Development. Assuring Equal importance for Documented Paper and Manufactured Product