Dr. Roopak Kumar

(Ph.D. in Analytical Chemistry)


Over 2 Decades of vast experience in Analytical Chemistry & Quality Control
Expert member of Chemistry
The Ayurvedic Pharmacopeia Committee
Pharmacopeia Commission for Indian Medicine (PCIM)
Department of AYUSH, Ministry of Health and Family Welfare, Government of India

Professional Profile
 Over two decades of experience in Analytical Research & Development, Quality Control, Commercial Laboratory Operations in the field of Pharmaceutical, Food, Pesticides, Oils and Fats, Cosmetics and related fields.
 Internal Auditor as per ISO 17025 (Quality Management System and Internal Auditor)
 Expert in Ayurvedic Pharmacopoeia Committee for Chemistry section..
 Have been leader in designing Analytical Laboratory, arranging Analytical Techniques for Pharmaceuticals, Food Products, Cosmetics, FMCG Products, Herbal Drug Research etc., starting from Green field project up to accreditation/Approval from concern Regulatory Authorities and generation of business.
 Experienced in Multiple Analytical Fields Ayurvedic Drugs, ABI, ABI Formulations API, API Formulations, Food Supplements, Cosmetics, Water Analysis, Natural Products and Formulations for routine Quality Control and Analytical Methods Development and their validation using Chemical, Chromatographic and Spectroscopic techniques.
 Well versed with Chromatographic Techniques e.g., HPLC (MS, MS/MS, UV/VIS, PDA, RI, and ELSD) HPTLC, GC (MS, FID, TCD and ECD), Spectroscopic Techniques e.g., UV/VIS, IR, ICP-MS, AAS etc.
 Actively involved in Heading/leading the Quality Audits conducted for in-house routine Quality checks and by external agencies e.g., NABL-ISO 17025, BIS, EIC/EIA, MOH of different countries etc.
 Well versed in Filing Normative Documents, Analytical Method Validation, Stability Studies, Environmental monitoring and Process Validations.
 Proficient in Qualifying (IQ/OQ/PQ) maintenance, calibration & troubleshooting of analytical equipments, thereby enhancing productivity and compliance to Regulatory requirements.
 Have been task oriented, cost effective and Quality conscious.
 Great zeal to work for Nation.
Academic Credentials
 Ph.D in Analytical Chemistry “HPLC Determination of Some Bio-active Phyto-constituents comprised of Non Chromophoric moieties by Evaporative Light Scattering & Photodiode array Detector”, from Choudhary Charan Singh University, Meerut (UP), 2005-2010
 M. Sc. (Specialization in Drugs & Pharmaceuticals and Oils, Fats & Soaps Analysis) Ist Division; Institution Of Chemists (India) Calcutta (WB), 1996
 P. G. Diploma; “Commercial Methods of Chemical Analysis” from Gurukul Kangri University Haridwar, India 1st division (1989)
 B. Sc. (Gurukul Kangri University Haridwar, India (1988)
Short-term coarse/Trainings/Seminar Attended
 German Language- Six month’s course from Max Muller Bhavan, New Delhi, a branch of Goethe Institute. Dated: 4th Feb 2002
 Participated in International Conference on Chemistry Biology Inter gace: Synergistic New Frontiers organized by Dr. BR Ambedkar Centre for Biomedical Research, University of Delhi. Dated 21-16th November 2004
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 One week long training on “HPLC methods Development” at Shimadzu Asia Pacific Center, Singapore. Dated 6-8th Dec 2005
 MBA (TQM and IPR) from National Institute of Management, Mumbai. Dated: 2008
 Participated in Training in Drugs Regulations as a resource Person for WHO Sponsored from DPR Korea conducted by the Drug Control Department, Govt of NCT of Delhi held at F-17Karkardooma, Delhi. Dated: 9-30th Dec 2009
 Residue Analysis; 5 Days course by SARAF (School For Advance Residue Analysis in Food organized by European Commission DG Trade at Kochi, Dated: India 22 to 26th Nov 2010
 Participated in Global Technology Forum on Food Safety on 10-11th November 2011  A 4 days training programme on Laboratory Quality Management System and Internal Audit as per IS/ISO/IEC 17025: 2005 held on 19 to 22th March 2013  A 3 days training programme on Measurement Uncertainty as per IS/ISO/IEC 17025: 2005 held during 10-12th July 2013 at Multani Pharmaceuticals Limited (Analytical Division) Khasra No. 37, Village Makkanpur Mehmood Alam, Pargana Bhagwanpur, Tehsil Roorkee, Distt. Haridwar (Uttarakhand) India
Approvals
1. Approved Analytical Chemist: In Chemical and Instrumentation by Office of the Controller Food and Drug Administration (MP) F. No. V/Anachem/15/2007 for Authorized Signatory Form 39 (Drugs and Cosmetic Acts).
2. Approved Analytical Chemist: In Chemical and Instrumentation by Govt. of NCT of Delhi Drug Control Department, Delhi. F. No. W26 (8)/Lab/DC/Vol-I/16753/12-03-2010 for Authorized Signatory Form 39 (Drugs and Cosmetic Acts).
3. Approved Analyst: In Microbiological Analysis of Drugs by Govt. of NCT of Delhi Drug Control Department, Delhi. F. No. W26 (8)/Lab/DC/Vol-I/13001/02-12-2010 for Authorized Signatory Form 39 (Drugs and Cosmetic Acts).
4. Approved Quality Control Staff (Analyst) for Ayurvedic and Unani Drugs Vide Approval No. DTL-1/A & U/ISM/539 by Govt. of NCT of Delhi, Office of the Directorate of ISM & H Tibbia College Campus, Karol Bagh, New Delhi-110005 (India)
5. Approved Analytical Chemist: In Chemical and Instrumentation by “The Directorate & Licensing Authority” Ayurvedic & Unani Services Uttarakhand, Dehradun for the testing of Ayurvedic, Siddha and Unani Drugs or Raw materials used in the manufacture thereof on behalf of Licensees.
6. Approved Person-In-charge for Carrying out the Tests or Analysis on Ayurvedic, Siddha and Unani Drugs or Raw materials used in the manufacture thereof on behalf of Licensees Form 49 (Refer Rule 160-I) from Licensing Authority Ayurvedic and Unani Services Uttarakhand, Dehradun (India)
7. Approved Person-In-charge for Carrying out the Tests of Drugs/Cosmetics and Raw materials used in the manufacture thereof on behalf of Licensees Form 37 (Refer Rule 150-C) from Drug Licensing & Controlling Authority Uttarakhand, Dehradun (India)
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Industrial Experience
(From Current to Initial one)
Current Employer
M/S Multani Pharmaceuticals Limited & Analytical Division, Roorkee (Uttarakhand)
Post: Centralized Government Approved Laboratory Head cum Quality Head
Duration: Since 16th July 2012 to till date.
Preface: M/S Multani Pharmaceuticals Limited (Analytical Division) is a Government approved (By The Directorate & Licensing Authority” Ayurvedic & Unani Services Uttarakhand, Dehradun & The Drug Licensing and Controlling Authority Drug Control Department of Allopathic & Homeopathic Services Uttarakhand Dehradun) and NABL Accredited in Chemical and Biological categories.
Role and Responsibilities:
Responsible for entire operation of Laboratory, which includes; Staffing, Technical updation, Business and further expansion. Reporting to Head of Organization.
Laboratory is catering the needs of testing of Internal as well as external customers additionally taking care of entire Quality related activities in units and external suppliers. Our Laboratory has been designed, constructed, got government approval and NABL accreditations in record time (Less than 2.5 years). Started business and currently, our laboratory is approved by more than 200 National and Multinational Companies for their support in Quality Control and Research Activities. Laboratory has also been approved by several Government organizations (GMSD, BPPI, State Governments) during this period only. Currently, our Laboratory is most preferred choice in North India for Quality conscious customers.
Ex-Employers:
1) Arbro Pharmaceuticals (Analytical Division) New Delhi
Post: Laboratory Head
Duration: From 15th July 2009 to 14th July 2012
Preface: Arbro Pharmaceuticals Limited (Analytical Division) is a Govt approved testing laboratory, which is engaged in the testing business of Drugs (Allopathic, Ayurvedic, Sidhdha, Unani, Food Products, Water, Agricultural and Dairy Products in India and Abroad in their Day to Day R&D, Quality Control Activities.
Laboratory is approved by UNOPS, NAFDAC, NABL, BIS, Spice Board of India, AYUSH, CCRAS, FDA India, DST India, Export Inspection Council of India, APEDA and so on.
Laboratory is also providing training to People working in Quality Control, Analytical Research and Regulatory Agencies on Chromatographic, Spectroscopic, Chemical Analysis and Microbiological Analysis at National and International platforms.
Role and Responsibilities: Overall responsible for Technical Operations in Laboratory, which comprised of above 100 Scientists working in different discipline of Analytical Science? Major disciplines are Pharmaceuticals Science (Method Development and Validation for API and Pharmaceuticals (All dosage forms) using Chromatography, Spectroscopy, Chemical Analysis and Microbiology. Few Methods for Vitamins have also developed using PCR and RT-PCR for Vitamins and Aflatoxins.
Prime person in Organization to support Customers and Training to people.
2) Plethico Pharmaceuticals Ltd. Indore (MP)
Post: General Manager (Quality Control and Analytical Development)
Duration: July 2006 to July 2009
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Preface: Plethico is engaged in the manufacturing of several Herbal Drugs products available in Global market either as Herbal Drugs or Food Supplements. Company is also invlb=ved in the manufacturing if Allopathic Drugs products (Tablet, Capsules, Cough Syrups, Dry Injectable, Liquid Injectable), Food Supplements etc. Company has got several manufacturing units located in India and abroad.
Role and Responsibilities: Undersigned was overall responsible for Quality Control and Research & Development for Analytical.
3) Ranbaxy Research Laboratories Ltd. Gurgaon (Haryana) as Research Scientist for about 2.5 years. (March 2004-July 2006)
4) Dabur Research Foundation, Sahibabad, Ghaziabad (UP) as Research Scientist for about 8 years. (April 1996-March 2004)
5) Phoenix Pharmaceuticals Pvt. Limited, Sohna, Gurgaon for about one year in Quality Control-Analytical Development. (June 1995-April 1996)
6) Montari Industries (Ranbaxy’s Associate) Limited, Toansa, Ropar (Punjab) for about 6
years in Quality Control. (June 1989-June 1995)
Key Functional Areas
Laboratory Operations
– Monitoring compliances to maintain GLPs in Laboratory with respect to adherence to laid down SOP, Quality systems and environmental monitoring.
– Managing routine maintenance and calibration (AMC & PMC) of analytical equipments on a regular basis for higher productivity and efficiency.
– Maintaining Quality standards for incoming materials, ensuring stringent adherence to Quality standards, norms & practices, identifying gaps and taking corrective action.
– Proficient in ensuring compliance of various Quality measures such as GLP/ GMP by maintenance of appropriate requisite documentation/ records.
– Conducting various tests & inspections to ensure that products developed are in compliance with pre-set technical specifications with adherence to concepts like TQM etc.
– Imparting training to staff regarding, GLP, Hazard Analysis, Health, Safety, Hygiene & preventive care of critical equipments. Developing, record keeping & updating documents / formats.
Process/ Product Development
– Monitoring Stability Study to assign shelf life of products.
– Conducting Technology Transfer & Demonstration of Analytical Techniques to Quality Control Departments of subsidiaries units of Organization.
– Investigating the market complaints using Analytical Tools in Finished products.
– Ingredient Interference studies during product Development.
– Carrying out Analytical Method Validation with documentary support for Drug Regulatory Affairs.
Environment Control
– Arranging periodic monitoring of Environmental monitoring in Sterile and non sterile area through different mode of techniques (Air Sampling, Plate exposure, Temperature and Humidity control etc.)
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Documentation
– Preparation of STP, SOP and Specifications etc., for Raw materials, Intermediates and Finished products.
– Preparation of Normative Documents of Products to be registered in Different Countries.
– Maintaining and peer-review documentation such as laboratory notebooks, electronic data collection/storage software, instrument logbooks, training records, etc.
– Ensure compliance of various Quality measures such as, GLP, by maintaining requisite documentation/ records. Preparing daily & periodic laboratory reports for information, compliance & corrective action.
– Writing/reviewing detailed documents like process (Trend Chart) and cleaning validation protocols.
– Preparation of Monthly Reports, Annual Product Reports & Periodic Product Review etc.
Significant Achievements;
 Developed several HPLC methods to analyze, more than two or three ingredients in a formulation of different nature in a single go.
 Developed several HPLC methods for Poly herbal formulations to quantify Herbal Extract based on their respective marker compounds in micro g level.
 Developed HPLC methods for Non-chromophoric compounds using HPLC ELSD technique.
 Several patent filed through Employer for HPLC methods in Natural products analysis.
 Trained 100th of Chemists/Scientists, who are working in Indian Industries/Education hubs and abroad successfully.
Publications and Achievements:
High Performance Liquid Chromatography Standardization of Centella Asiatica and its Marketed Formulations. The Pharmacist 4(2) 31-34 (2010). Patents: Preparation of sweetener tablets of stevia extract by dry granulation methods WO 2006072879 A1, Application number: PCT/IB2006/000016,
Inventors: Anil Kanaujia, Chandra Kant Katihyar, Roopak Kumar, Avinash Narwaria, Arvind Padiyar, Yogita Rani, Rahul Singh
Applicant: Anil Kanaujia, Chandra Kant Katihyar,Roopak Kumar, Avinash Narwaria, Arvind Padiyar, Ranbaxy Laboratories Limited,Yogita Rani, Rahul Singh

Last modified: Monday, 22 February 2016, 3:37 AM