Truly committed professional in a highly challenging and stimulating environment where I use my technical skills contributing informatively in the growth of organization. Total 18 plus years of experience in the field of Clinical development Goal-Directed, results-oriented, professional with a strong clinical research background and education. Trained on ICH-GCP. Successfully completed good number of projects (All therapeutic areas) as Investigator starting from protocol development to report submission, besides 3 Oncology, 1 infectious disease. Took it as a challenge and completed 2 CNS patients based studies in less duration and have involved in various phase trials execution in diabetes, orthopaedics and other therapeutic studies also was Investigator for two vaccine phase I trials. Actively participated in 30+ regulatory audits (6-USFDA, 12-DCGI, 4-ANVISA, 4-WHO, 2-MOH-Turkey, 2-UKMHRA and 2-EMEA). Trained in preparing market intelligence reports, trial tracking by larvol group. Have the potential for leading and shouldering teams in the achievements of project milestones. Have played a major role in setting up CRO for BA/BE, patient studies, Pharmacy and Archival for Global markets. Currently working as Co-Investigator in Phase I and Phase II, vaccine trials for COVID of domestic and International companies.
Over 12 years of experience in Manufacturing of Fine Chemicals, Active Pharmaceutical Ingredients, Pharmaceuticals, Combined Wastewater treatment Plants and Hazardous waste Management Facilities. Over 19+ years of experience of third party Auditing and training with Certification Bodies such as RWTUV, TUV Rheinland Group, BSI- MEA, LRQA-MEA and GMCSPL- India
He is an expert- senior Lead Auditor and Trainer in the fields of Quality ISO 9001, Occupational Health and Safety OHSAS 18001, ISO 45001, Environment ISO 14001, Hazard Analysis and Critical Control Points HACCP, Food Safety Management Systems ISO 22000, Responsible Care 14001, Energy Management 50001. Qualified Internal Auditor in accordance with ISO 17021, ISO 17020 and ISO.
Prof (Dr) Giriraj T Kulkarni is working as Professor Principal, Gokaraju Rangaraju College of Pharmacy, Bachupally, Hyderabad. He has a total teaching and research experience of 27 years and has guided 55 M Pharm dissertations and 15 PhD research scholars. He has published 145 papers in various national and international journals and 12 books and book chapters through various international publishers such as Elsevier, Informa, etc. He also has 75 papers in various national and international conferences and has 16 patents to his credit.
He is life member of various organizations including APTI, IPA, IPGA, SPER, SPDS and SSX. He has received various awards which include Gold Medal from Gulbarga University in B. Pharm (1992), 36th IPC Award for securing first rank in B. Pharm (1992), IDMA (Indian Drug manufacturers’ Association) Best Paper Award (2002), APTI Best Paper Award (2010), International Travel Award from Tefarco Innova Italy (2005), APJ Abdul Kalam Research Thinker Award 2019 (Students’ Choice) from Amity Institute of Pharmacy, Amity University Uttar Pradesh, Pharma Ratna-2019: Best Professor Award from Rab Di Mehr Foundation, Delhi, National level first prize from SPDS for the paper presented in DRPI-2020, Teacher Recognition Award from Together We Can Foundation, Ambala Cantt, Haryana (2021).
His papers have received more than 2000 Citations, h-index is 27 and i10-index is 51. Total Impact Factor is more than 100.
The areas of research interest include natural excipients, hydrogel technology, nanotechnology for drug delivery, herbal drug delivery systems for neurological disorders and infectious diseases
Selected as Guest Editor of ‘Natural Product Radiance’ (NISCAIR, New Delhi), to bring out a Special Issue on ‘Herbal Cosmetics and Cosmeceuticals’ (July-August 2005). Worked as Regional Editor of ‘Advances in Medical and Dental Sciences’ (American-Eurasian Network for Scientific Information, Jordan).
Working as Editorial Board Member of ‘Pharma Research Journal’ (Online, Sudarshan Publishers, Ghaziabad), Indian Journal of Pharmaceutics (Serials Publications, New Delhi), International Journal of Pharmaceutical and Applied Sciences, Published by ijpasonline.com, Mehsana, Journal of Cell and Tissue Research, Published by Society for Science and Environment, Rajkot. Working as Editor-in-Chief of Journal of Chronotherapy and Drug Delivery (www.chronotherapyjournal.net).
Reviewer for Current Drug Delivery, Published by Bentham Publishers, Pharmaceutical Research, Published by Springer, Carbohydrate Polymers, Published by Elsevier, Natural Product Radiance, Published by NISCAIR, New Delhi, Journal of Cell and Tissue Research, Published by Society for Science and Environment, Rajkot, Pharmacognosy Magazine (Phcogmag), Published by Pharmacognosy Network, Bangalore, World Applied Science Journal, Published by wasj.org, Pharmaceutical Biology, published by Informa, USA, Maejo International Journal of Science and Technology, Published by Maejo University, Thailand (www.mijst.mju.ac.th), Drug Development & Industrial Pharmacy, European Journal of Pharmaceutics and Biopharmaceutics (Elsevier).
Selected as Chairperson of a Poster Session in 62nd Indian Pharmaceutical Congress, Held at Manipal, during 17-19 December 2010.
Conducted 15 workshops / conferences as Chairperson / Convener / Organization Committee member, and attended 26 conferences in India and abroad as Resource person / Delegate.
A senior Finance professional with over 25 years of progressive experience in different industries, having raised over INR 10 Bn borrowings and having been reporting to board for last 8 years on corporate affairs. A FCA, AICWA, DISA, CS (E) and LLB with multi-industry experience in entire gamut of Finance and Accounts. Proven ability in strong business acumen and decision making with well-developed leadership quality. Possess strong team building capability, cost control ability (Lean Management and Six Sigma- Green Belt practiced), Quality Reporting and robust Financial Management.