Tina Conkic


1st January, 1970

Tina Conkic

CURICULUM VITAE 

Tina Conkic

DOB: 17.11.1968, Belgrade, Serbia
Phone +972525282873;
e-mail: tinaconkic@gmail.com
Address: HaHalutz 46/8 Nahariya Israel

Professional skills:

  • Clinical trials:
  • Coordination of Clinical Trial Material / Investigational Product supply to clinical sites according to Local legislation, Sponsor’s SOP and GCP / GDP / GMP
  • Coordination of Clinical Trial Material / Investigational Product use on clinical trial sites according to Local legislation, site’s SOP and GCP
  • Training of clinical / pharmacy personal on all aspects of drug accountability (including preparation of treatment)
  • Training of clinical personal on use of medical devices (when applicable)
  • Quality control:
  • QC laboratory team leadership
  • Organization of QC laboratory according to GMP
  • Planning and execution of Development and Validation of Analytical and Biochemical methods according to GMP, USP and PhEur
  • Auditing of QC laboratory methods and results
  • Preparation of regulatory required documents according to GMP (SOP, methods, reports…)

 Personal skills:         

High ability of learning, approaching and adapting to new environment, communicative with excellent personal skills.

Languages:

Hebrew (written & spoken)

English (written & spoken)

Serbian (written & spoken, mother tongue)

French  (written – basic knowledge)

Spanish (written – basic knowledge)

Professional experience:

March 2010. – Present: Protalix Biotherapeutics

Drug accountability coordinator / Manager

  • Establishing GCP based documentation system for CTM / IP use within Clinical Trials

(Including writing Clinical Trial documents relating to CTM / IP)

  • Monitoring Clinical Trial Materials use for compliance with GCP

(by either performing monitoring visit reports at sites or reviewing and approving monitoring visit reports from subcontractor CRA/monitors)

  • Training clinical trial personal and/or CRA/monitors
  • Shipping validation planning according to GMP / GDP / GCP

May 2007. – March 2010: Protalix Biotherapeutics

QC laboratory Team Leader

  • Team management
  • HPLC methods development and validation
  • TOC method development and validation
  • Establishing system for raw material quality control

(development of methods for raw material identification by Raman Spectrophotometer)

January 2006. – May 2007: Protalix Biotherapeutics

QC manager

  • Establishing Quality Control laboratory within bio-technology start-up company
  • Pre-validation analytical/biochemical R&D method change to QC laboratory and GMP standards
  • Team management

October 2004. – December 2005: Shemen Industries

Laboratory  manager

  • Laboratory team management
  • Management of central laboratory providing services for five factories from “Shemen” industry group, performing analysis of vegetable oil (soy, corn, sunflower, canola, palm, olive), soy meal, soy protein, margarine and soy lacityn.

May 2001. – October 2004: Shemen Industries

Analyst in chemical laboratory

  • Performing analysis of final product (vegetable oil, soy meal, soy protein) and in-process product
  • Establishing new laboratory facilities (purchasing, verification and use of new analytical equipment, including SOP preparation and team training)
  • Development and verification/validation of analytical methods (GC, HPLC, NIR IR, Keidahl, Fibertec…) for analysis of food products and water.
  • Writing and implementing SOP according to ISO.

July 2000. – May 2001: Tambour Colour Industry

Analyst in in-process laboratory

  • Performing analysis of in-process and final powder color product
  • Performing analysis for product development
  • Working according to the ISO 9002

September 1996. – July 2000: Dexxon pharmaceutical Industries

Analyst/team leader in clinical laboratory

  • Developing and validation of analytical methods for blood/plasma analysis within bioequivalence clinical studies
  • Preparing Protocols and Reports for bioequivalence analytical results
  • Performing analysis on GC (ECD), HPLC (UV, FLUO)
  • Working according to GLP

Education:

June 2010:       CRA qualification course, Bioforum, Israel

1997 – 2005:   Numerous professional courses in field of HPLC and GC

1984 – 1987.      Chemical technician

Dr Dusica Stefanovic high school, Belgrade, Serbia

Recommendations will be provided as required.

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