Quality Control Manager
Resume:
Curriculum Vitae
KSENIJA BRZILOVA
**-** ***** **., ******* Point,
NY 11356
Mobile number 347-***-****
*********@*******.***
EDUCATION AND HONORS
University of Saint Cyril and Methodius, Faculty of Pharmacy, Skopje, Macedonia
Graduated Pharmacist (equivalent to Master in Pharmacy)
May, 2001
GPA 3.15
Licensed Pharmacist: May 2003 –Present
License number: 07-869/2
Licensing Board, Pharmaceutical Chamber of Macedonia
Professional Exam taken on: 05/22/2003
University of Saint Cyril and Methodius, Faculty of Pharmacy, Skopje, Macedonia
Specialization in Examination and Control of Medicines, April, 2008
Specialization thesis: “Forced degradation study performed on active pharmaceutical ingredient Lisinopril dihydrate and finished product Skopryl tbl 10mg and Skopryl tbl 20mg”
European Compliance Academy (ECA): Certified Quality Control Manager,
October, 2010
PROFESSIONAL EXPERIENCE
ALKALOID AD, Skopje, Macedonia (June , 2001–June 2011)
Generic pharmaceutical industry, privately-owned
Scientist, Area Leader, Analytical laboratory of Research & Development Department (September 2007 – June 2011)
* Responsible for development and validation of HPLC and spectrophotometric analytical methods for determination of the quality of finished products
* Performing forced degradation studies on API and finished product
* Writing Common Technical Documents (CTD) Module 3 parts for Registration Dossiers for Submission:
- 3.2.P.5.1. Specification(s)
- 3.2.P.5.2. Analytical Procedures
- 3.2.P.5.3. Validation of Analytical Procedures
- 3.2.P.5.4. Batch analyses
- 3.2.P.5.5. Characterization of Impurities
- 3.2.P.5.6. Justification of Specification(s)
- 3.2.P.6. Reference standards and Materials
- 3.2.P.8.3. Stability Data
* Writing SOPs for R&D analytical laboratory
* Knowledge of evaluating Pharmacopoeias data (USP, PhEur, BP), Guidelines (FDA, ICH and EMEA), and literature data
* Acquiring and reviewing Drug Master Files (DMF) for API’s from suppliers
* Writing and performing Analytical Transfer Protocols
* Responsible for communication with external collaborators and in- house departments
* Ensuring all activities are performed in accordance with the corporate standard operating procedures (SOPs), GLP/GMP guidelines and safety standards
* Performing analyses for development and stability purposes
* Presentation of the results to Director of R&D Department with ideas for further research
* Specific equipment experience: Waters Acquity Ultra Performance LC with PDA Detector; Waters Alliance with Photodiode Array Detector; Hitachi Elite La Chrom HPLC; Varian Pro Star HPLC; Varian Cary 50 UV-Visible Spectrophotometer; Varian dissolution apparatus, Karl Fischer apparatus.
* Good written and oral communication skills.
Scientist, Area Leader, Analytical Laboratory of Quality Control Department (June, 2001 - August, 2007)
* Performing HPLC and spectrophotometric analyses for determination of the quality of the finished product and in stability studies
* Validation of HPLC and spectrophotometric analyses
* Performing forced degradration studies on API and finished product
* Ensuring all activities are performed in accordance with the corporate standard operating procedures (SOPs), GLP/GMP guidelines and safety standards
* Writing SOPs for QC analytical laboratory
* Responsible for the daily activities and results in analytical laboratory in QC department
Intern - Medical Union Pharmaceuticals Cooperation (MUP)
Cairo, Egypt, Jul. – Aug. 1998
* Under supervision of the Quality Control Manager conducted: chemical analysis of finished products, preparation and standardization of volumetric solutions, operation of several instruments (IR, dissolution apparatus, spectrophotometer, ph-meter, and tablet/suppository disintegrator), analysis assay using HPLC gas-chromatography
Student Exchange Officer - Macedonian Pharmaceutical Student’s Association
Faculty of Pharmacy - University Ss. Cyril and Methodius
Skopje, Macedonia, Feb.1998 – Oct. 2000
* Organized the placement of students at retail pharmacies, hospital pharmacies, wholesale companies, pharmaceutical industry, and schools of pharmacy, government, and private health agencies
* In collaboration with the IPSF Student Exchange Chairperson and Committee, led internal and external communication and advice, constantly working towards expanding the student exchange program
* Organized seminars, summer-schools, and bilateral exchanging study tours
TRAINING AND PARTICIPATIONS
* Summer School (Thermo Electron Corporation) – Liquid Chromatography, Mass Spectrometry, Belgrade, Serbia, September, 2006;
* 4th Congress of Pharmacy with International Participation, Belgrade, Serbia, December, 2006;
* 4th Black Sea Basin Conference on Analytical Chemistry; Sunny Beach, Bulgaria, September, 2007;
* 4th Congress of Pharmacy with International Participation, Ohrid, Macedonia, September, 2007;
* Workshop ( Agilent Technologies) – New perspectives for last HPLC using micron packing material, broader pressure, flow and temperature range of analytical equipment on Agilent 1200RR system, Ohrid, Macedonia, September, 2007;
* Workshop ( Agilent Technologies) – New developments in sample throughput for purity and assay determination using new electronic pressure control and capillary flow technology on Agilent 7890GC system, Ohrid, Macedonia, September, 2007;
* Seminar – Impurities in Pharmaceutical Products, Vrsac, Serbia, November, 2007;
* European Compliance Academy (ECA, Concept Heidelberg) – Maximising HPLC Productivity: Combining Science and Compliance in a GMP Laboratory, Barcelona, Spain, April, 2008;
* Phenomenex Seminar – Reversed Phase HPLC Method Development, Using Phenomenex HPLC Phases, Skopje, Macedonia, October, 2008;
* Borer Training Course – Designing an Effective Cleaning Process, Skopje, Macedonia, November, 2008;
* European Compliance Academy (ECA, Concept Heidelberg) – Impurities: Detecting, Identifying, Quantifying, Specifying and Reporting, Prague, Czech Republic, May, 2009;
* 5th European Generic Medicines Association South East Europe Pharmaceutical Symposium, Ohrid, Macedonia, September, 2009;
* European Compliance Academy (ECA, Concept Heidelberg) – Dissolution Testing, Berlin, Germany, October, 2010;
* Waters Educational Services – Empower 2 Software Advanced Topics Training Course, Skopje, Macedonia, December, 2010;
PUBLICATIONS
Brzilova K, Bozinonoska I, Babunovska H.
“Development and validation of HPLC methods for determination of assay of BHT and Ascorbic Acid in Hollesta film coated tablets”
4th Congress of Pharmacy with International Participation, Belgrade, Serbia, December, 2006
Brzilova K, Babunovska H.
“ HPLC method for determination of impurities formed in oxidative degradation of CAFFETIN tablets”
4th Black Sea Basin Conference on Analytical Chemistry; Sunny Beach, Bulgaria, September, 2007
Brzilova K, Babunovska H.
“Forced degradation study performed on Lisinopril dihydrate active pharmaceutical ingredient”
4th Congress of Pharmacy with International Participation, Ohrid, Macedonia, September, 2007
LANGUAGES
* Fluent in written and spoken English, Croatian, Serbian, and Macedonian (native language)
* Proficient in Italian, Spanish and Bulgarian
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