QC Chemist

ZANA ALEKSI

****-*** ******* ***,

Toronto, ON M*B 1K2

Tel:416-***-****; Mobile: 416-***-****

***********@*****.**

HIGHLIGHTS OF QUALIFICATIONS

• Over nine years of hands-on experience in Pharmaceutical laboratory environment

• Post-graduate diploma in Pharmaceutical QA/QC and M.Sc. in Biotechnology

• Worked in compliance with GMP, FDA and ICH, requirements

• Practical knowledge of USP and British Pharmacopoeia

• Computer skills: MS Office, CHEMSTATION, EMPOWER, Atlas software for HPLC, WINFIRST software for FTIR, Agilent for UV-Vis. LIMS -> LabC21/SmartLab/SAP programs

• Excellent command in using and troubleshooting HPLC, UV, (USP I, II and IV)

• Capable of handling multiple assignments high pressure and consistently meeting tight deadlines

• Self-motivated, detail-oriented, cooperative team player, eager to learn

• Excellent interpersonal and communication skills demonstrated through effective teamwork, a professional attitude and motivation to produce high quality work

• Very good organizational and time management skills

EMPLOYMENT HISTORY

Chemist June 2007-Present

GlaxoSmithKline Mississauga, ON, Canada

• Performed analytical tests : Assay, Content Uniformity, Identity, Impurities, testing of solid dosage finished product for release and stability studies using HPLC , UV/VIS, TLC

• In accordance with established GMP's, GLP's and SOP's, performed dissolution test on solid dosage forms using extreme competence in the following areas:

*Various Sotax & VanKel dissolution equipment (USP I, II and IV daily)

• Documented, interpreted and reported test results within the scheduled time interval

• Ensured that all necessary corrections were executed in accordance with cGMP standards.

• Notified department supervisor/manager regarding omissions, incomplete testing results or other irregularities

• Protocols and SOPs were followed.

• Assisted in investigations of OOS results; participated in self-inspections

• Worked within the laboratory in a team environment; assisted with QC initiatives; actively participated in QC projects and team meetings

• Attended workshops and training courses; attended in-house SOP and GMP training

Chemist March 2004-June 2007

Bodycote Testing Group, Mississauga, ON, Canada

• Managed/Coordinated stability studies and also executed stability protocols

• Authored: methods, stability protocols, stability reports, method equivalency protocols and other technical documents.

• Coordinated project management tasks by following-up actions and communication internally and externally.

• Reviewed stability protocols.

• Kept a detailed record of all experiments, collected data and completed report summaries

• Verified the integrity and traceability of all stability data generated and reported

• Presented technical reports

• Researched and gathered information for different chemical entities

• Developed and validated methods for elution of control released drugs on USP IV Dissolution Aparatus

• Performed Method transfer on HPLC and Dissolution Apparatus USP I, II and USP IV

• Contributed, as part of a team of science professionals, to meeting/exceeding business objectives

• Trained junior chemist to perform Dissolution USP I, II and IV analysis and result interpretation.

• Wrote SOPs for analytical methods and SOPs for maintenance and calibration of instruments such as: Dissolution Apparatus USP I, II and IV, UV/Vis spectrophotometer, pH meter

• Reviewed validation documentation, including stability protocols, raw data and summary reports for equipment qualification, process and cleaning validation to ensure compliance.

• Experienced in identification and troubleshooting of analytical and minor instrumental problems

• Performed calibration of Dissolution Apparatus (USP I and II)

Analytical Chemist 1998-2000

Nish Profarma Inc. (Pharmaceutical Company) Tirana, Albania

• Audited the analytical lab in accordance with GMP

• Calibrated pH meter, analytical balances, dissolution apparatus, UV Spectrophotometer, HPLC, GC

• Conducted chemical analysis on raw materials, in-process materials and finished products using specialized instruments and apparatus such as High Performance Liquid Chromatograph (HPLC), Ultra-Violet spectrophotometer, Fourier-Transform spectrophotometer (FT-IR) and Gas Chromatograph (GC), Dissolution Apparatus

• Wrote Standard Operating Procedures for analysis and equipment

• Validated and maintained laboratory equipment as necessary

Quality Control Analyst 1997-1998

Albanian Alimentary Oil Association, United States Agency for International Development

Tirana, Albania

• Determined the adulteration in olive oil using HPLC

• Used FT-IR, and Raman spectroscopy for a rapid determination of adulteration of extra virgin olive oil

• Investigated different aromatic compounds present in olive oil by using UV technique

• Performed various routine laboratory analysis, measurements and experiments

Research Associate 1994-1997

International Center for Advanced Studies, Greece

• Established protocols for a plant which is used medicinally and ornamentally

• Adjusted testing equipment and prepared culture media, reagents, buffers and solutions following standard procedures.

• Used regulated autoclave for sterilization and performed all laboratory work in Laminar airflow to maintain aseptic conditions for invitro culturing

• Established and maintained primary tissue and cell cultures; cloning in soft agar and by limited dilution

• Collaborated with other research institutions involved in the project

EDUCATION

Pharmaceutical Regulatory Affairs and Quality Assurance May 2008-On

Seneca College, Toronto, Ontario

Post-graduate Diploma in Quality Assurance/Quality Control 2002-2003

Toronto Institute of Pharmaceutical Technology, Toronto, Ontario

M.Sc Degree in Biotechnology 1996

International Center for Advanced Mediterranean Agronomic Studies, Greece

Equivalent to Ontario Master’s Degree

Member of Pharmaceutical Sciences Group 2003

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