CURRICULUM VITAE PERSONAL INFORMATION Name DIMITRIU LAVINIA CRISTINA Nationality Romanian Date of birth 13 August 1957 Sex Employer / Field of activity WORK EXPERIENCE female Antibiotice Quality Unit 25 September 2007 to date Quality Director in the quality management system according to GMP requirements, Management Representative on the Integrated Management System (Quality, Environment, Occupational Health and Safety) and qualified person in manufacture/import of pharmaceutical products for human use. Planning, organizing and coordinating the Quality Department to ensure compliance with regulatory requirements for the manufacture of pharmaceutical products and active substances Organizing and coordinating the establishment, implementation, maintenance and development of requirements for the integrated management system (quality, environment, occupational health and safety) Assessing and enforcing compliance with GMP requirements in the planning and realization of investments Performing the incumbent as a Qualified person Manufacture of basic pharmaceutical products 23 September 2005 to date Quality Director in the quality management system according to GMP requirements, Management Representative on the Integrated Management System (Quality, Environment, Occupational Health and Safety) Planning, organizing and coordinating the Quality Department to ensure compliance with regulatory requirements for the manufacture of pharmaceutical products and active substances Guaranteeing that each batch of finished product released on the market was produced and tested/controlled in accordance with the GMP requirements, national applicable regulations and the MA. Manufacture of medicines and pharmaceutical products January 2003 to date Quality Director ( Quality Assurance and Quality Control) Planning, organizing and coordinating the Quality Department activity to ensure compliance with regulatory requirements for the manufacture of pharmaceutical products and active substances Guaranteeing that each batch of finished product released on the market was produced and tested /controlled in accordance with the GMP requirements, national applicable regulations. Manufacture of medicines and pharmaceutical products 1
August 2000 January 2003 Quality (Laboratory of physico-chemical and microbiological analyses) Quality Control Manager Manages and organizes laboratory work of physico - chemical and microbiological analyses Manufacture of medicines and pharmaceutical products August 1990 August 2000 1987 1990 1985 1987 1981 1985 Production Manager, Parenteral Products Plant Planning, organizing and coordinating the activity within the Plant in view of achieving the production program at the quantity and a quality level set Achieving the production program, compliance with quality parameters stipulated in the specifications, contractual norms or arrangements, delivery terms stipulated in the contracts, both for the domestic market and for export Applying the most efficient methods for organizing, programming and monitoring production Improving the production flows and the work process Applying the research results in production and solving the productionrelated problems Manufacture of medicines and pharmaceutical products Foreman - Lysine Manufacture Coordination of the technological process development in the media preparation, biosynthesis and atomization installations, in shifts Manufacture of medicines and pharmaceutical products Technologist at the Design Center Făgăraş Chemical Factory Manufacture of polycondensation resins phenol - formaldehyde Head of the Quality Control Lab Făgăraş Chemical factory Manufacture of polycondensation resins phenol - formaldehyde Education and formation GMP 13 17 September 2010 Certificate for continuous training 2
1. Training GMP for quality assurance and control, modules 1-8: Media fils ICH and FDA regulations on aseptic filling Recommendations for the validation of aseptic processes Media fill used for validation Media fill for routine use Training and qualification of staff Requirements for documentation 2. Monitoring environmental conditions Environmental considerations: standards, qualification and monitoring clean rooms Monitoring of airborne microbial load and non-viable particles Monitoring non-viable particles Microbial monitoring Monitoring interventions 3. Risk management system Risk management with an impact on quality (MRC) with respect to aseptic processes and finished products such as tablets, capsules, ointments and suppositories, active substances obtained by biosynthesis. MRC process Evaluation of risk, control, communication and revision Risk evaluation tools Risk analysis in 3-D, FMEA, HACCP, FTA The implications of risk analysis/evaluation on processing Implications of risk determination on the validation 4. Investigation of the primary cause for CAPA Cause-effect investigations CAPA process development Problems related to the human factor and CAPA training CAPA: Too much or not enough? Review 483 and CAPA quotes Using a closed system as the center of activity for quality management 5. Residual solvent testing Classification of solvents by risk analysis/assessment The interaction between laboratory and API manufacturer Selecting methodologies i. Screening methodologies ii. Method validation iii. Routine testing vs. qualification testing Chromatography Challenges from the past Case studies 6. Theory and Practice of Near IR (near-infrared) in the pharmaceutical industry What is the use of NIR? History and basic theory Applications in the Pharmaceutical Industry The price / benefit ratio in production and productivity The development of quantitative predictive models Using the portable NIR analyzers 3
7. Developing the HPLC method and validation procedures - Efficiency of the HPLC method development process i. critical components for the HPLC method ii. % time spent with various stages of development l iii. The elaboration of the method development experiment - Deadline for method development - Defining method objectives - Understanding the chemical aspects - Conditions of the initial method - Preparation of samples - Standardization - Optimizing method - Method validation 8. Pharmaceutical impurities - ICH requirements for the control of impurities in pharmaceutical products - Impurities associated with the API (active pharmaceutical ingredient) - Organic impurities - Inorganic impurities - Residues of solvents - Impurities concerning /concerned with formulation - Impurities during formulation - The formation of impurities during the "ageing" - Critical factors affecting the bulk product quality - Appropriate packaging - Use of the method of production based on the stability studies - Measures adopted by the Pharmacopoeia Novatek International 28 31.05.2008 25 September 2007 28-29 May 2007 13 June 2006 Conference Strategies for Compliant Pharma Sourcing EFCG (European Fine Chemicals Group) in Lisbon, Portugal Certificate attesting the capacity of qualified person in the manufacture/ import of medicinal products for human use Qualified person in the manufacture/ import of medicinal products for human use Ministry of Public Health, National Agency for Medicines, Bucharest Certificate for continuous training US-FDA Drug Submission Procedures Pharmaceutical Training International Millipore Biopharmaceutical Seminar Millipore, Bucharest, Romania 4
25 October 2005 Certificate for continuous training Millipore Steriltest School Course Millipore, Bucharest, Romania 27 30 September 2005 Certificate for continuous training Aseptic Processing and Sterile Processes Institute of Validation Technology (SUA), with the participation of trainers from FDA Dublin 26 27 January 2005 FDA s New Quality Systems and Risk Approach Heidelberg University, Germany 13 Decembrer 2004 Veterinary Generics in the E.U Management Forum, Lonon, UK 11 12 November 2004 Certificate of continuous training CTD, CEP and DMF Quality of Drug Substance, European Compliance Academy, Barcelona, Spain 27 30 September 2004 Certificate of continuous training Computer System & Software Validation Institute of Validation Technology (US), with the participation of trainers from FDA Dublin 03 04 May 2004 Process Analytical Technologies EDQM, Cannes, France 14 October 2003 October Pharma Fest Symposium 5
TEKNOLEB, Bucharest 06 October 2003 Seminar: Le marche du flaconnage verre pharmaceutique et cosmetique Saint-Gobain Desjonqueres, Bucharest 22 25 September 2003 Certificate of continuous training 07 09 July 2003 Cleaning Validation of Critical Cleaning Processes Institute of Validation Technology (US) Dublin, Ireland Certificate of continuous training Pan European Regulatory Forum on Pharmaceuticals (PERF III) EMEA, Ljubliana, Slovenia 02 June 2003 Diploma of attendance Seminar New Analytical Methods for Pesticide Residues in Foods and Agricultural Products Agilrom Scientific, Buharest, Romania 26 27 November 2002 Certificate of continuous training European Aseptic Conference 2002 04.12.2006-16.12.2006 European Compliance Academy, Barcelona, Spania Certificate of continuous training, ISO Course on Occupational health and Safety M.M.S.S.F Labor inspection 30 March 2006 Certificate no. 6935 Environmental Management 31 March 02 aprilie 2006 Certificate no. A 256 Quasaro, lecturer eng. Tatiana Samoilă (Auditor of AFAQ-ASCERT International no. A00558, Head Auditor RENA no. A0107) Internal auditors for the Environmental Management System 6
03 April 2006 Certificate no. 6940 04 06 April 2006 Certificate no. A 37 07 11 November 2005 Certificate 06/0644 Quasaro, lecturer eng. Tatiana Samoilă (Auditor of AFAQ-ASCERT International no. A00558, Head Auditor RENA no. A0107) Management System for Occupational Health and Safety OHSAS 18001 Quasaro, lecturer eng. Tatiana Samoilă (Auditor of AFAQ-ASCERT International no. A00558, Head Auditor RENA no. A0107) Auditors for the Management System for Occupational Health and Safety Quasaro, lecturer eng. Tatiana Samoilă (Auditor of AFAQ-ASCERT International no. A00558, Head Auditor RENA no. A0107)) LRQA course for Auditor/ chief auditor for series ISO 9000:2000 International Register of Certificated Auditors IRCA 29 august 01 September 2005 certificate TRI-AK/05/16581 Specialist in Quality management TUV Rheinland InterCert Budapest 06.2012-07.2012 Summer School a+, Edition III, module I Creativity, innovation and improvement, Lecturers from Alexandru Ioan Cuza University, Faculty of Economics and Business Administration Qualification / Diploma obtained 06.2011-07.2011 Summer School a+, Edition II, module I Creativity and innovation, module III Labour legislation, modulul VI Methods of statistical analysis in quality assurance and quality control Lecturers from Alexandru Ioan Cuza University, Faculty of Economics and Business Administration 29.06. 09.07.2010 7
Summer school a+, Edition I, Management and development in the turbulence era Lecturers from Alexandru Ioan Cuza University, Faculty of Economics and Business Administration 2007 to date Doctoral School 2006 2007 The faculty of Medicine and Pharmacy, Iasi Postgraduate studies MA in Pharmaceutical Management and Marketing The Faculty of Medicine and Pharmacy Iasi 10 March 2005 14 July 2005 Certificate of English upper intermediate English language course EuroEd foundation 19 October 2004 24 February 2005 The certificate of English language intermediate English language course EuroEd foundation 18 June 2004 National Symposium Quality is everybody s problem Quality - Management European Integration, Bucharest 21 23 April 2003 Workshop on Designation and notification of regulatory bodies in the EU in the field covered by New Approach directives; Designation and notification of regulatory bodies in Romania in the field covered by Law no. 608/2001. RENAR Bucharest 26.03.2003 30.09.2003 Postgraduate course on Organizational culture Alexandru Ioan Cuza University Iaşi 8
November 2000 Diploma of attendance National Symposium: Quality is everybody s problem RENA Bucharest 17 01.1999 Graduate School of management, stage I Gh. Asachi Technical University Iaşi 17 21 December 1992 HR Management course Department of Education and Training within the Board of Commerce and Industry 23 November 12 December 1992 Training for using microcomputers Computer Training Center 15 April 19 April 1992 Personnel Management Course 11 March 22 March 1991 Department of Management and Training for the Domestic and Foreign Market, Antibiotice SA Industrial Management and Marketing Department of Management and Training for the Domestic and Foreign Market, Antibiotice SA 1989-1990 Graduation Diploma 1976 1981 Postgraduate specialization in Biotechnology Alexandru Ioan Cuza University Iaşi Graduation diploma The Faculty of Chemical Technology Gheorghe Asachi Polytechnic Institute, Iaşi 9
Personal skills and competences Perseverance Mother tongue Romanian Foreign languages Self-evaluation e Understanding Speaking Writing Europeann level (*) Listening Reading skills Conversation Oral production English French B2 C1 Independent Expert B2 Independent C1 Expert B2 B2 Independent Independent (*) Common European Framework of Reference for Languages B2 B2 Independent Independent writing C1 Expert C1 Expert Social skills and competences Organizational skills and competences Technical skills and competences Technical skills and competences Artistic skills and abilities Other skills and abilities Driver s license Additional information Interpersonal communication skills, efficiency, dynamism, team spirit, reliability, resistance to stress Coordination skills, planning and organization, ability to identify and solve problems, reviewing skills, leadership skills, decision making skills, strategic thinking Management skills, ability to evaluate and make decisions, ability to synthesize Microsoft Office: Word, Excel, Power Point B category Available upon request 10