1. CURRICULUM VITAE
NAME: Anat Tal
CITIZENSHIP: Israeli
POSTAL ADDRESS: 18 Hashita St., Omer 84965, ISRAEL
TELEPHONE: 053 -2854860
E-MAIL ADDRESS: anatit@hotmail.com
EDUCATION:
M.Sc. Microbiology
Hebrew University, Jerusalem, ISRAEL
High Diploma in Education (post graduate)
Science and Biology
WITS University, Johannesburg, RSA.
COURSES:
CRA – Monitoring of Clinical Trials, Bioforum.
On-going regulation updates and professional courses
Quality Risk Management; PDA (Parenteral Drug Association)
GMP Instructors Course; Teva, Chemical Division.
Quality Assurance ISO-9000 (5 months)
Internal Quality System Auditing; Bywater
Writing Product Annual Review; Biolog and ECA courses.
Quality Improvement Process (60 hours)
LANGUAGES:
Fluent English and Hebrew
COMPUTER SKILLS:
Microsoft Office
QA Track (a TrackWise application)
Internet
2. 2
PROFESSIONAL EXPERIENCE
2015 Technical Writer
Hy-Laboratories, Science Park Tamar Rehovot
Composing protocols, reports and SOPs for the microbiology service
laboratory
2003 – 2014 Technical Writer and Special Projects Coordinator
QA Department, Biotechnology General (BTG)
Ferring Group, Israel
Compliance with Pharmaceutical Quality System requirements.
Follow up on Regulatory Guidelines and Pharmacopeia updates and
literature survey.
Writing policy documents (e.g. Quality manual, Site Master File)
protocols and reports (e.g. Annual Product Review / Product Quality
Review, validation protocols and reports) and standard operation
procedures (SOPs) according to regulatory bodies requirements (e.g.
FDA, EU, ICH, PIC/S).
Compiling Quality / Technical agreements.
Risk Management activities.
Coordination of deviation investigation, CAPAs and special projects
(e.g. environmental monitoring, HVAC system, IPC results).
Conducting internal audits.
Complaints handling.
GMP training.
1999 – 2003 Coordinator of Validation of Analytical Methods
QA Department
Kamada Ltd. Manufacturer of Pharmaceutical products
Beit – Kama, Israel
Coordinating the activities involved in the validation of analytical
methods according to GMP guidelines. Conducting data and statistical
analyses of validation results, writing validation protocols and reports.
GMP training of new employees.
3. 3
1997 – 1998 Quality Assurance Coordinator
QA Department
Teva Tech, Teva Chemical Division
Ramat Hovav, Beer Sheva, Israel
Coordinator of QA activities. Responsible for the implementation,
assimilation and maintenance of the quality system in the plant according
to GMP regulations.
1995 – 1996 Quality Assurance Co-ordinator
Koffolk Ltd. Manufacturer of Veterinarian API
(Active Pharmaceutical Ingredient)
Ramat Hovav, Beer Sheva, Israel
QA coordinator in a veterinary BPC manufacturer. Preparing the plant for
an FDA inspection through implementation of GMP regulations in the
various departments. Assuring compliance from the receiving of raw
materials through the manufacturing process and maintenance to packaging,
quality control and the release of batch files. Preparation of SOPs and
validation reports, supervising and conducting staff training.
1991 - 1994 Research Assistant
Department of Zoology, WITS University
Johannesburg, RSA
Research in the fields of cell & molecular biology, including biotechnology
& genetic engineering: The study of the transcriptional regulation of the
ras2 gene in Drosophila and its application in oncogenesis.
1988-1990 Research Assistant
Iron & red Cell Unit, WITS Medical School
Johannesburg, RSA.
Study of iron absorption in humans at the molecular, cellular and
physiological levels. Work involved application of techniques used in the
fields of molecular and cellular biology, assay development and interaction
with patients.
4. 4
1981-1987 Senior Chemists in QC Laboratories
SASOL Two: Oil and Chemicals from coal
Secunda, RSA
Support to synfuel plant, problem solving & method development,
monitoring microbial growth in petrol & cooling water.
Hands on experience with gravimetric, volumetric, potentiometric and
spectrophotometric(IR, UV/VIS & AA) techniques.
Operation, optimisation, trouble shooting and basic maintenance of gas
and liquid chromatography apparatus.
The use of common methods in microbiology e.g. culturing, extraction
and analysis of micro-organisms.