Padmaja Naishadham

A certified lead auditor for QMS, I work as a consultant and industry coach for Pharma majors in the following areas: - Analytical Method Development and Validation of APIs - Analytical Research and Development - Drug Investigation, recalls and return methods. OOS, OOT, CAPA, change controls of QMS - Quality Assurance and Quality Control - GMP and GLP - Training for Pharma Industry staff and senior management for the above areas

- Responsible for handling overall Quality Assurance, Quality Control and Analytical R&D activities- - Accountable for implementation of regulatory guidelines, GMP, ICH guidelines, WHO and Vendor Qualifications - Worked on Analytical Method development and Method Validation and handled OOS, OOT, deviations and product recalls

- In charge of handling overall Quality Assurance, Quality Control and Analytical R&D activities - Handled Analytical method Development, Testing and Validation of all samples received from internal labs & from all over the world using NMR, HPLC, LC-MS, GC, GC-MS, HSGC, TGA, DSC, CHNS, FTIR & wet methods. - Reviewed development reports, Tech transfer documents, method validation reports, project management, process and Implementation of QMS and conducted periodical Management Review Meetings ((MRMs) - Took complete responsibility to obtain ISO 9001-2015 certification identifying risks in every process with risk-mitigation plans, including closing of minor NCs with corrective actions.

- DGM- QA, Responsible for obtaining Organic Certificates from Vedic Organic Certification Agency, Telangana State Seed Certification Agency. - Responsible for Quality Assurance & quality systems, review of development reports, method validation reports, project management, Internal audits, process validation, equipment qualification, CAPA assessment reports. • Review of method transfer protocols & reports and other laboratory records. Part of the internal compliance team. Review of equipment and facility qualifications, process validations, handling of deviations, change controls, market complaints, internal audits, compliance of Quality Management

- Accountable for quality, delivery and compliance to GLP, FDA and other regulatory requirements - Institutionalised high quality standards in AR&D through revised SOPs and subject training in the department. - Developed, validated and reviewed specifications and test methods of all the materials of Natco Research Centre - Addressed deviations, investigated OOS samples and analysed failures with CAPA. - Reduced lab OPEX costs by 27% through strategic sourcing (tri-vendors). - Established collaboration programs with Premier Educational & Research Institutions to co-innovate on new analytical methods and analysis.

Lead AR&D team, reviewed Validation Protocols and established Quality Management System

- Professor of Analytical Chemistry for post graduate students (M.Sc) of Osmania University & PG Diploma students of Quality Assurance and Management and acted as Additional Controller of Academic branch, Osmania University. - Structured analytical chemistry syllabus suitable for industrial applications, in close liaison with scientists at IICT, Dr. Reddy’s Laboratories, NGRI, NIPER, VIMTA labs etc. - Arranged projects for PG students in close interaction with industry leaders like NMDC, NGRI, Dr. Reddy’s Laboratories, Matrix Labs, Aurobindo Pharma, Vimta labs, CMET, CCCM.

Analysed APIs and inspected raw materials and finished products as QA officer as per FDA guidelines.