Academic Qualifications:
M. Sc. , Organic Chemistry, Andhra University
B. Sc. , Mathematics, Physics & Chemistry, Andhra University

Experience in Regulatory Affairs:
Compilation of Drug Master Files for USA, EU, Korea and Near Regulatory markets.
Preparation of responses to USDMF deficiencies and Queries.
Preparation of responses to European regulatory deficiencies [DCP, MRPs, CEP queries etc. ]
Customer queries responses and finalizing customer specifications, agreements, declarations etc. ,
Planning for Updating, Amending of Drug Master Files for USDMFs, EDMFs, & Renewals for CEPs etc. ,
Regulatory Guidance to Manufacturing, Quality Control and Quality Assurance in reducing works, by initiating reduced testing, etc. , activities and Change management, followed by amendments to the DMFs etc. , and as per the latest regulations like ICHQ8, CHQ9, CHQ10
Change control management- Assessing and updating Changes in Manufacturing process, equipment, specifications, etc. , w. r. t to all market DMFs. [US, EU, apan]
Review of Manufacturing, Testing, validation and technical reports relevant to submission of Drug Master Files and technical packages.
Ensure Regulatory compliance at Manufacturing Cycle of all submitted Products, regulatory guidance of Manufacturing, Quality Control, and Quality Assurance.

Experience in Quality Assurance:
Review of Development reports prior scale up of technology in plant scale & participate in technology transfer meets to ensure proper scalability of product.
Design, review and approve validation protocols and reports. Conduct validation closure meets for successful completion of process.
Review and approve potential changes to process/documents / facility and equipments and provide updates to regulatory on Summary Of changes.
Participate in critical quality OOS/OOT & deviation investigations, Customer complaint investigation and close the Deviations, Complaints in a timely and with an effective CAPA timely.
Participate in regulatory and customer audits. Coordination of Periodic Internal Quality Audits [cross functional] to have system on the track.
Monitor vendor evaluation procedures (Vendor assessments on site-vendor audit).
Compile Annual product reviews and implement recommendations/ conclusions
Implementation, monitoring of Corrective action and Preventive actions related to Market complaints, Critical deviations, Internal and External audits and OOS.
Coordination in the qualifications of the equipments’/clean rooms to see whether equipment/clean rooms meets all the design specifications and performs consistently and for clean rooms in order to avoid cross contamination.
Implementation of SAP for the tracking and controlling the movement of material as per the laid down procedures by training on the subject.
Conducted GMP celebrations in the facility to know the GMP consciousness in the personnel and enhance their skills in quality aspects.
Major Role in successful clearing of the Australian TGA, DMA, USFDA, exican, KFDA, PMDA /Customer/Regulatory authorities’ inspections in companies i worked.
Implementation of eBPR in the manufacturing area.