Niranjan Jena

Background

About Niranjan Jena

Having 19 years of experience in Quality Assurance in reputed Pharma organizations. • Exposed to regulatory audits like USFDA (12 times), MHRA (7 times), ANVISA (5 times), WHO (7 times), TGA (5 times), MCC (3 times), HSA Singapore (3 times) and MNC customers (GSK, Sandoz, Mylan, Abbott etc.) for solid oral, semisolid and parenteral dosage forms. • Acquired key skills on Quality Management system designing, Implementation, Controlling and Maintenance, Process Quality Assurance, Equipment and Area Qualification, Process Validation, Quality Risk Management, setting up new the facility, Updating GMP Documents as per Regulatory Amendments, Process Requirements and Conducting Training Sessions for Various Quality Modules. • Acquired auditing and audit handling skills and compliance. • Computerized system validation and review of audit trails. • Well versed with Track Wise for the handling of QMS documents, SAP, OAMS, MT-Application, DMS, LIMS,e-BMR & UL compliance ware for training management.