nandakumar v v madiki
Published on: Mar 3, 2016
Transcripts - nandakumar v v madiki
nanda kumar v v madiki
Address for communication:
C-11, Apuroopa Colony,
Hyderabad- 500 055, INDIA.
Phone: +91 9849203297
Highly Quality oriented professional with having an extensive background experience in API, Formulation industry and serving
Production, Quality Control, Quality Assurance, Research and Development, Analytical Development & validation, and Regulatory
Affairs in the Bulk Drug (API) Industry as well as in formulations (Tablets) and semi formulations. Exposure on handling various
Regulatory Audits successively without any observations. I wish to associate with an organization where I can utilize my skills and
creativity to improve business opportunities.
♣ Licensing activities
♣ Registration of products at Regulatory Agencies,
♣ Filing Drug Master Files and responding to queries raised by the Agencies
♣ Marketing Authorization to customers for filed products
♣ Evaluating the various sections of the DMF to ensure the regulatory compliances
♣ Monitoring Regulatory compliance in the organization
♣ Communication with Regulatory agencies and customers for all regulatory related aspects and drug master files
♣ Submissions of annual updates, variations to the agencies as per the timelines and responses to deficiencies etc.
♣ Evaluating the new guidelines and train the staff accordingly.
♣ Conducting meetings and given the time schedules to complete the activities according to the deficiencies
♣ Registration of facilities, dossiers at agencies and ensure the validities of their status
♣ Submitted more than 20 DMFs to various agencies
♣ Exposure on various Regulatory Agency regulations
♣ National and International Regulatory audits
♣ Communication with DCGI, local DCA for COPP (WHO GMP) and product licensing.
♣ Experience in with US, EU, Canada, Brazil, Australia, New Zealand and ROW countries.
♣ Process evaluation/ approval
♣ Preparation, review and approval of SOPs and validation protocols followed by Validation Reports
♣ Implementing cGMP systems
♣ Plant equipment qualification, Facility qualifications, clean room qualifications
♣ Process/ cleaning / analytical method validations, analytical method development, Regulatory and Customer audits;
successive completion of USFDA, TGA, KFDA, MHRA, EDQM, EU-GMP and WHO- Geneva audits
♣ Vendor development, qualification and monitoring/ rating etc.
♣ Change controls, MDIRs, Deviations, Out Of Specifications and Internal Audits
♣ Training and evaluation
♣ Technology transfer document review and method transfers
♣ Master Formula Record, Master BMR preparation, review and approval
♣ Regulatory and Customer audits
♣ Setting objects to various departments for improvement, evaluation of the action plans against objects.
♣ Handling Customer complaints, Root cause identification, Investigations, CAPA, Response to complaints and closing
handling non-conformance products
♣ Handling Internal audits
♣ In-Process parameter evaluation
♣ Wet lab analysis/ trouble shooting
♣ Qualification of laboratory instruments
♣ Instrumental qualification, calibration and analysis like UV-Vis and FT-IR spectrophotometers, HPLC, GC and other
♣ Analytical method developments, validations and transfer etc.
♣ QC training
♣ Monitoring regular analysis
♣ Verification of validation and stability protocols; monitoring stability programme
♣ Implementing Quality documentation in the laboratory
♣ Review of SOPs and other related documents
♣ Implementing Good Laboratory Practices
♣ Implementing Quality Systems to meet various Regulatory guidelines
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♣ Laboratory budgeting and manpower recruitment
♣ Reduction in cost of analysis through propose alternate analytical methods
♣ Participating and monitoring OOS investigations and customer complaint investigations
♣ Planning for timely delivered outputs on priority basis
Research and Development:
♣ Process alteration/ modification for cost reduction through retro synthesis
♣ Product development
♣ Synthesis of Impurities
♣ Preparation of Impurity profiles
♣ Qualification of standards and forced degradation studies
♣ Preparation of Process Development Reports
♣ Technology transfers
♣ Process evaluation
♣ Critical Process Parameter identification
♣ Yield improvement
♣ Manufacturing Discrepancy investigation
♣ Production related training to the concerned
♣ Process Validation
♣ Trouble shooting
♣ Process modifications, if required etc.
♣ Production planning and inventory control
♣ MS- word, excel
♣ Successively completed without major observations in various Regulatory Audits like USFDA, MHRA, KFDA, EU-GMP
and EDQM audits
♣ Successive completion of ISO 9001 and 14001 certifications as Management Representative
♣ Submitted 27 DMFs to various regulatory agencies and got approved; submitted COS for different products to EDQM
♣ Development of sulphasalazine product on own and successively transfer the technology.
♣ Spectroscopic, Chromatographic and potentiometric Analytical method development and their validation and transfer of
analytical methods along with technology transfer
♣ Evaluation of Impurity Profiles
♣ Filing DMFs
♣ Demonstration of analytical method validation at customer’s end
♣ Development of cleaning method validation by HPTLC
♣ Creativity thinking and effective planning.
♣ Successive completion of WHO-GMP (Geneva) Audits
Having more than 25 years of hands on experience in API industry and serving Production, Quality Control, Quality
Assurance and Regulatory Affairs departments. At present, working with Admiron Life Sciences Private Limited as
Head-- Quality and Regulatory Affairs since June 2013-
MBA in Total Quality Management
Master of Science in Chemistry
Post Graduate Diploma in Chemical analysis and Quality Management
Bachelor of Science in Chemistry
♣ Analytical Method validation and trouble shooting on Chromatography, certified by American Chemical Society.
♣ Analytical Method validation and trouble shooting, certified by Agilent and BDMA.
♣ Post Graduate Diploma in Chemical analysis and Quality Management.
♣ Analytical Method validation on HPTLC, certified by Camag.
♣ One day training program by Mr. Peter Smith of Saxon International.
♣ ISO and GMP training programme.
♣ Knowledge on Statistic Quality Control
Name : M.V.V.Nanda Kumar
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Father’s name: M.Appa Rao
Date of birth : 07.07.1968
Marital status : Married
Nanda Kumar V V Madiki
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