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.