1. Curriculum Vitae
Personal Data
Name
Iveta Margina
Date of birth 17/6/1977
Address
j.k. Peio Yavorov, block 8, entr.B, 5-th floor, Dupnitsa 2600, Bulgaria
Мobile +359895661670; +359884596059
E-mail ivetamargina@yahoo.com
Work Experience
Period October 2012 -present
Company Alvogen Pharma Trading Europe EOOD
Industry of Work Experience Pharmaceuticals
Location Sofia, Bulgaria
Position Qualified Person/ Quality Assurance
Job Level Expert Staff
Responsibilities QA review/QP release of 3rd
party products
Management of Quality system- Handling of Deviations, CAPA
Complaints, Product Recalls, Risk Assessments, Assessment
of Annual Product Review and Stability Data; Self inspections
Coordinator of training on corporate level
Period
April 2009 – May 2011
Company Actavis "Balkanpharma-Dupnitsa" AD
Industry of Work
Experience
Pharmaceuticals
Location Dupnitsa
Position Qualified Person at Quality Affairs

2. Job Level Expert Staff
Responsibilities Reviewing of Batch Manufacturing and Packaging Records of medicines,
produced at the factory and medicines, produced under Technical agreement
contracts ;reviewing and approving of master documentation related to products,
produced under Technical agreements; reviewing and managing of deviations;
preparing of SOP’s for activities related with quality control; coordinating the
activities related to the commission of complains; reviewing and assessment of
registered in Batch Records Deviation Reports; certified that the medicinal
products are produced and controlled in compliance with Manufacturing
Authorization, presenting Batch release procedure during the audits and external
inspections.
Period
January 2009 – April 2009
Company Actavis"Balkanpharma-Dupnitsa" AD
Industry of Work
Experience
Pharmaceutical
Location Dupnitsa
Position Chemist
Job Level Non-managerial Expert Staff
Responsibilities Testing of finished products
Period
December 2007 – January 2009
Company Actavis "Balkanpharma-Dupnitsa" AD
Industry of Work
Experience
Pharmaceuticals
Location Dupnitsa
Position Senior Validation specialist at Quality Assurance
Job Level Non-managerial Expert Staff
Responsibilities Preparing validation protocols and plans, validation of manufacturing and
packaging processes, preparing Validation Reports
Period
March 2006 – December 2007
Company Actavis "Balkanpharma-Dupnitsa" AD
Industry of Work
Experience
Pharmaceuticals
Location Dupnitsa
Position Specialist at Quality Control, Qualified persons unit
Job Level Non-managerial Expert Staff
Responsibilities Reviewing of Batch Manufacturing and Packaging Records of medicines,
reviewing of analytical protocols of starting, bulk and finished products,
participating in inspections, preparing of Annual product review
Period
November 2000 – December 2002

3. Company Siemens Westinghouse
Industry of Work
Experience
Electronic components
Location Charlotte, North Carolina, United States
Position Office Assistant
Job Level Non-managerial Expert Staff
Responsibilities Taking inventory, keeping records and sorting checks, preparing documents,
process mail and answer telephones.
Education
University/Higher Education
University/Higher Education
Medical University, Sofia, Bulgaria
Period November 2005 - May 2007
Degree n/a; Specialized course for non-
pharmaceuticals, working in the
pharmaceutical industryas Qualified Person
on Quality
Major Special training for EU QP laid down in
Article 49 of Directive 2001/83/EC related
to medicinal products for Human use and
Article 53 of Directive 2001/82/EC related
to veterinary peoducts
University/Higher Education
University/Higher
Education
Higher Institute of Chemical technology and Metallurgy, Sofia
Period September 1995 - October 2002
Degree Master of Science
Major Engineer - Chemist, Silicate materials
High School
High School
“Hristo Botev” School - Dupnitsa
Period
September 1991 – May 1995
Type of School
Humanitarian school
Additional Skills, Competencies and Achievements
Languages
English -Upper Intermediate level – English Language Institute at the American
University in Bulgaria, Pitman Examination Institute, UK

4. IT skills
Organizational
skills and
competencies
Microsoft Office (Word, Excel, Power Point); Internetworking with Microsoft
Internet Explorer;
Microsoft Outlook Express
Team working, prioritizing, completion of task within stringent timeframes
Driving License Yes
Other Certificates
2015 QP Regulatory Preparation Workshop- McGee Pharma International
2010 5th
Qualified Person Forum – Concept Heidelberg, London
2009 Batch Record Review- European Compliance Academy
2008 Advanced Tablet Press Operation – Accreditation Council For Pharmacy
Education
2008 Powders, Granulation, tablet and capsule technology – The Center for
Professional Advancement
2007 Tablet production for operators and supervisors - The Center for
Professional Advancement
2007 Pharmaceutical coating technology - The Center for Professional
Advancement
2007 RCA, CAPA & OOS – Pharmaceutical training International
2007 Biochemistry - Medical University Sofia
2007 Pharmaceutical Chemistry and Pharmaceutical Analysis – Medical
University Sofia
2007 Pharmacology – Medical University, Sofia
2007 Toxicology - Medical University, Sofia
2007 Pharmacognosy - Medical University, Sofia
2006 Internal auditors of Quality Systems ISO 9000:2000- QAC, Sofia
2006 Pharmaceutical Technology and Bio pharmacy- Medical University, Sofia
2006 Human Anatomy and Physiology – Medical University Sofia
2006 Microbiology - Medical University Sofia