CONSULTANT. In Quality Management and Quality Control of Vaccine

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1 ; Curriculum Vitae Rochapon Wacharotayankun Address : 25/163 Moo 2 Sanamchan Subdistrict, Muang Nakhonpathom District, Nakhonpathom 73000, THAILAND. Mobile: +66 (0) rochapon@gmail.com; wrochapon@yahoo.com; CURRENT EMPLOYMENT Deputy Managing Director -Ferno Co., Ltd. April 2015 to Present PROFESSIONAL EXPERIENCE CONSULTANT In Quality Management and Quality Control of Vaccine JULY 2014 PRESENT As a consultant of PATH - an international, nonprofit global health organization, provide training, audit and guidance on Quality Assurance and Quality Control to support vaccine and biological products manufacturers in China to ensure compliance with ICH guidelines, WHO and International Good Manufacturing Practices. As an independent consultant, provide training and guidance on Quality Assurance and Quality Control to support Biotech and vaccine manufacturers to establish and improve Quality management and Quality control systems according to WHO and International Good Manufacturing Practices. QUALITY ASSURANCE SENIOR MANAGER BioNet-Asia Co., Ltd. JANUARY 2015 MARCH 2015 Manage the Quality Assurance department (Evolution of the Quality Operations department to separate one Quality organization into 2 departments, namely -Quality Assurance and Quality Control departments and to harmonize position names companywide). The organization covers 4 key functions of Quality Assurance, i.e. Quality systems, Operational quality (Shop floor quality), Batch release and Qualification & Validation. Head Pharmacist and Qualified person of the company. Recruit, train, coach, develop, motivate and manage the Quality Assurance team consisting of 12 staff to ensure strict compliance with the Quality Practices in Biomedical Research, ICH guidelines, International and local Good Manufacturing Practices and other relevant GxPs for Biological Products. Implement the International and local Good Manufacturing Practices for Investigational Medicinal Products Manage the Biorisk Management System covering Biosafety and Biosecurity in compliance with the local regulation and the European standard CWA International and Local GMP inspection readiness to support product licensing. HEAD- QUALITY OPERATIONS BioNet-Asia Co., Ltd. JULY DECEMBER 2014 Establish the Quality Operations department by reorganizing the Quality Assurance and Quality Control departments into one Quality organization, in BioNet-Asia which is the first Vaccine R&D and Manufacturing Company in Thailand. The Page 1 of 6

2 organization covers 5 key functions, i.e. Quality systems, Operational quality (Shop floor quality), Batch release, Validation and Quality Control laboratories -Biology, Chemistry, QC support, Animal House and Sterility Assurance laboratories. Head Pharmacist and Qualified person of the company. Recruit, train, coach, develop, motivate and manage the Quality Operations team consisting of 26 staff 9 QA and 17 QC to support Research & Development of vaccines, Preclinical and Clinical study phases of Vaccine Development to ensure strict compliance with the Quality Practices in Biomedical Research, ICH guidelines, International and local Good Manufacturing Practices and other relevant GxPs for Biological Products. Implement the WHO Quality Practices for Biomedical Research (QPBR) for Research & Development of Vaccines. Implement the International and local Good Manufacturing Practices for Investigational Medicinal Products. Establish and implement the Biorisk Management System covering Biosafety and Biosecurity in compliance with the local regulation and the European standard CWA Incorporate the ICH Q9: Quality Risk Management and ICH Q10: Pharmaceutical Quality system into practice. Set up the Control laboratories with their management system to develop and facilitate analytical development of new vaccines, manage new test development including animal testing and method validation / verification and stability studies. Manage the Control Laboratories to comply with Good Clinical Laboratory Practices (GCLP). Design the Control laboratories and Animal house buildings of the company in compliance with cgmp and Biosafety requirements. Support for the design of Production facilities for bacterial and viral vaccine- upstream processes as well as fill-finish and warehouse facilities. ANALYTICAL PROCESS TECHNOLOGY SENIOR MANAGER (Regional Position) Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP), Gateway Thailand* MAY JUNE 2011 *Joint Venture between the Government Pharmaceutical Organization (Government Enterprise), and Sanofi Pasteur International, France with a contribution of the Royal Crown Property of Thailand Manage and implement analytical process technology (APT) for analytical process development and continual improvement in Control laboratories of sanofi pasteur industrial operation sites in Asia, including India, Bangladesh, Indonesia, China and Thailand. (Regional position in a newly established global organization of sanofi pasteur). SITE QUALITY OPERATIONS SENIOR MANAGER Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP), Gateway Thailand JANUARY 2008 APRIL 2011 Set up and manage Site Quality Operations Organization which is a new organization established in GPO-MBP following the global direction of sanofi pasteur, and a steering system of the quality activity including Quality systems, Validation qualification and calibration strategy, Product quality including batch release process, Operational quality on the shop floor, Control laboratories, Incoming materials laboratory and Sterility assurance of products in strict compliance with Global plan, Policy, Directives, current Pharmaceutical Good Manufacturing/Laboratory Practices and products licenses. Recruit, train, coach, develop, motivate and manage the Site Quality Operations team consisting of 31 staff 9 QA and 23 QC. Lead Regulatory inspection of the site, i.e. Annual Thai FDA inspection, WHO Prequalification and Australian TGA inspection. Lead inspector of key suppliers, i.e. Schott Iglar Glass, Indonesia, LG Life Sciences, Korea, Shantha Biotechs, India. Safety and Cost control. Page 2 of 6

3 QUALITY CONTROL SENIOR MANAGER Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP), Gateway Thailand JULY 2002 JANUARY 2008 Manage quality control department including laboratory testing, product quality monitoring and environmental monitoring and sterility monitoring to ensure timely and cost-effective quality control of product in strict compliance with Pharmaceutical Good Manufacturing/Laboratory Practices and products licenses. Recruit, train, develop and motivate QC staff of 23 people in 4 laboratories. Set up analytical method validation system and stability study programs. Technology transfer of analytical methods for new vaccines development at GPO-MBP, i.e., Influenza vaccine, Measles vaccine, DTwP-HB vaccine, Oral poliomyelitis vaccine and ChimeriVax -JE vaccine. Safety and Cost control. SIGNIFICANT ACHIEVEMENT Quality Management System: Design,set up and implement the Site Quality Operations organization in GPO-MBP with support from Global quality organization of sanofi pasteur, France, Implement computerized system validation system at GPO-MBP, Implement systematic quality risk management in the key quality management systems, i.e. Out-of specification, Failure investigation, Change control, Supplier quality assurance, Environmental monitoring and Qualification/ validation, Design, set up and implement the Quality Operations organization at BioNet-Asia Co., Ltd. to support Research and Development of vaccine in compliance with the WHO Quality Practices in Biomedical Research (QPBR), Design, set up and implement the Quality Operations organization at BioNet-Asia Co., Ltd. to support Pre-clinical and Clinical studies of vaccine in compliance with the relevant ICH guidelines, WHO requirements and GMP for Investigational Medicinal Products, Design, set up and implement the Quality Operations organization (Quality assurance and Quality control) at BioNet-Asia Co., Ltd. to prepare for Vaccine manufacturing ( Cell banking, primary and secondary manufacturing) in strict compliance with the cgmp, ICH guidelines and local regulation. Quality Assurance: Lead GPO-MBP to successfully pass the Annual Thai FDA, WHO PQ and Australian TGA quality audits, WHO prequalification for Measles vaccine and TGA clearance for ChimeriVax -JE vaccine (Thailand as the country of origin of this novel vaccine), Lead BioNet-Asia to successfully pass the inspection of a European Biotech company for Active Pharmaceutical Ingredients supply according to the EU-GMP requirement, Qualified person for batch release of vaccines and investigational medicinal products, Lead auditor for International key suppliers, i.e. Schott Iglar glass, Indonesia, LG Life Sciences, Korea, Shantha Biotechs, India, Qualified auditor by DAVID BUCKLEY & ASSOCIATES PTY LTD. Design and set up Quality Assurance department at BioNet-Asia Co., Ltd. to support Vaccine manufacturing and Licensing phase. Quality Control: Implement the Quality control organization at GPO-MBP to ensure reliability of sampling and testing of products, Page 3 of 6

4 Set up the stability study and analytical method validation systems to comply with the cgmp and ICH guidelines, Analytical method development, optimization, transfer and validation for test methods of all vaccines including Rabies, Measles, MMR, OPV, Hepatitis-B, DTP-HepB, Influenza and ChimeriVax -Japanese encephalitis, at GPO-MBP, Set up and implement the Quality control organization at BioNet-Asia including Biology, Chemistry, Microbiology and Animal house, to ensure reliability of sampling and testing of R&D materials, preclinical and clinical materials, Analytical method development, optimization, verification and validation for Acellular pertussis vaccine, Hepatitis B vaccine, and Haemophilus influenzae type b vaccine. Preparation, testing and calibration of Thailand s Reference vaccines (Japanese encephalitis, Hepatitis B, Measles, Diphtheria and Tetanus) in collaboration with the Thai National Control Laboratory. Design 2 QC buildings (GPO-MBP and BioNet-Asia) and 1 Animal house (BioNet-Asia). Biorisk management System: Implement the Biorisk management system including Biosafety and Biosecurity according to the CWA at BioNet-Asia to comply with the local authority requirements, Biorisk professional certification (certified by Department of Medical Sciences, Ministry of Public Health, Thailand). Clinical Laboratory Management: Set up Clinical Laboratory at BioNet-Asia for Human serum testing (Immunological assay) to support Clinical studies, sponsored by the company in compliance with the WHO Good Clinical Laboratory Practices (GCLP) requirements and Biorisk management, Analytical method development, optimization, verification and validation of human serum testing procedure to support Acellular pertussis vaccine clinical trial. Project Management: Project manager for expansion of the Quality control building at GPO-MBP with the outstanding record in safety (award granted by the President of sanofi pasteur). Consultancy: PATH s consultant for China Biological Group (CNBG) for training and quality guidance since July 2014, PATH s consultant for a private owned vaccine manufacturer China in Quality assurance and Quality control, Independent consultant for a private owned Biotech company in China for establishment of Quality management system to support vaccine development. Others: Guest lecturer in several Faculties of Pharmacy for Quality assurance and Quality control of Biological Products, Guest speaker of Thai Industrial Pharmacist Association and National Vaccine Institutes, Member of several committees for developing and evaluation of Post-graduate curricula in Pharmaceutical sciences, Member of Technical subcommittee of the National vaccine institutes of Thailand Member of several committees/ working groups of the National vaccine institutes of Thailand. Page 4 of 6

5 OTHER WORK HISTORY : Faculty of Pharmacy, Silpakorn University, THAILAND o First Faculty member o Associate Dean o Associate Dean for Administrative Affairs o Associate Dean for Post-graduate Studies and Foreign Affairs o University council members o Chairperson of the University s Public Relation subcommittee for privatization of Silpakorn University o Head, Department of Biopharmacy (2 terms x 4 years) 1985: Warichapoom Hospital, Sakolnakorn Province o Hospital pharmacist : Ciba-Geigy (Thailand) o Medical representative PERSONAL INFORMATION Status : Born : Language: Married, 3 children 04 August 1958 in Thailand Thai, English (fluent), Japanese (little) EDUCATION : Ph.D. (Medical Science: Molecular Biology), Nagoya University, JAPAN : Master of Pharmacy (Pharmaceutical Microbiology), Chulalongkorn University, THAILAND : Bachelor of Pharmacy, Mahidol University, THAILAND PROFESSIONAL DEVELOPMENT Special Training 2001 Quality assurance for higher education- Ministry of University Affairs, Thailand 2002 Activity based costing-faculty of Pharmacy Silpakorn University 2002 Finance for non-financial Faculty of Pharmacy, Silpakorn University 2003 Inspection of manufacturer of biological products : David Donald- sanofi pasteur, France 2004 Stability studies: Rene Bouzinac- sanofi Pasteur, France 2005 Analytical method validation: Nicole Gibelin- sanofi pasteur, France 2006 Safety training for management: Department of Labour, Thailand 2007 Risk Assessment in quality: Rene Buzinac- sanofi pasteur, France 2008 Qualification and validation, Batch release, Change management: sanofi pasteur, France 2008 Validation of computerized systems: Richard Austin- sanofi aventis, France 2008 Quality risk management: Pierre Lauer- sanofi pasteur, France 2009 Computerized systems retrospective validation: Luca Barmer, ValCom, Italy 2009 Executive overview of ISO14001&OHSAS18001: Paul Robere Associates 2009 Risk & aspect assessment: Paul Robere Associates Page 5 of 6

6 2010 Site Quality Operations: sanofi pasteur, Canada Practical application of quality risk management: David Begg Associates 2010 Workshop on Batch release of vaccines: WHO (Beijing, China) 2011 Analytical method validation and stability study: Nadir Harjee, WHO consultant 2011 Good Laboratory Practices: Siripan Wongwanich,Department of Medical Sciences, Ministry of Public Health 2011 Biorisk professional training (I) : Department of Medical Sciences, Ministry of Public Health 2012 Biorisk professional training (II) : Department of Medical Sciences, Ministry of Public Health 2012 Safety training for organizational safety committee: Department of Labour, Thailand 2013 Internal auditor: David Buckley and Associates, Australia 2013 Design qualification: David Buckley and Associates, Australia 2013 Conference and workshop on stability studies of vaccines: WHO (Bangkok, Thailand) 2014 ISO14001/OSHA18001: Paul Robere Associates 2014 Good Clinical Practices (GCP): Simonetta Vivianni, Italy 2014 Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP): Rita, Switzerland 2014 Process validation, a risk- based approach: Nadir Harjee, WHO consultant Page 6 of 6