Yaara Dromi has over 10 years of experience in quality assurance and management roles in the pharmaceutical industry. She has led quality assurance teams and ensured compliance with regulations from agencies like the FDA and EMA. Her experience includes managing clinical supplies quality assurance at Teva Pharmaceuticals and serving as GMP Group Leader and Associate at Biotechnology General.

1. Yaara Dromi
7 Elaine Court, Bentleigh East, VIC 3165 ♦ Tel: 03 9017 0152; Cell: 04 2461 5655 ♦ email: yaara_dromi@yahoo.com
QUALITY ASSURANCE ♦ MANAGER/SUPERVISOR & AUDITOR
More than 10+ years experience in driving quality management strategies, compliance and leading change initiatives
within a production environment. Strong compliance focus, with the knowledge needed to integrate Quality Management
Systems, and drive audits for FDA, EMA, ISO and other health authority requirements. Expert in GMP (Good Manufacturing
Process), and effective knowledge of GCP, Annex 13, Annex 16, FDA 21 CFR and other relevant regulatory matters. Strong
risk-manage approach and skilled negotiator. Able to lead multiple levels of staff.
• QA/QC Frameworks • Continuous Improvement • GMP Management
• Clinical Studies • ISO & FDA Compliance • Internal Audit Management
• Supplier Audits & Compliance • OHS Certification • Quality Management Systems
• Clean rooms behaviour • SOPs Implementation • Supply Chain Improvement
• Vendor Management
• International relations with
suppliers and colleagues
• Staff Management • Writing Procedures
SELECTED HIGHLIGHTS
2013 to 2014 Head of Quality Assurance for Clinical Supplies | Teva Pharmaceuticals
2011 to 2012 GMP Group Leader | Biotechnology General
2008 to 2011 GMP Associate | Biotechnology General
2006 to 2007 Technical Support | Orgenics
2001 to 2004 Laboratory Technician | Sheba Medical Center
2000 to 2001 Laboratory Technician | Weizmann Institute of Science
PROFESSIONAL EXPERIENCE
Teva Pharmaceuticals Jan 2013 to Jun 2014
Teva Pharmaceutical Industries Ltd. is an international pharmaceutical company specialising in generic and proprietary pharmaceuticals
and active pharmaceutical ingredients, and employing over 46,000 staff.
HEAD OF QUALITY ASSURANCE for Clinical Supplies
• Drove the quality management strategy and plan, and led the daily efforts including managements and
resorts planning to deliver finished clinical products to clinical studies.
• Established and maintained key quality indicator elements, organised quality goals and objectives. Identified,
assessed and incorporated best demonstrated industry practices to assure GMP and regulatory compliance
with all local and international applicable regulatory requirements and applicable guidance documents.
• Reviewed and approved documentation relating to clinical supplies including the review and approval of
supplier plan documents, and study supplier performance documents and final release for clinical studies.
• Built relationships between the QA division and supply chain management.
• Oversaw quality aspects of clinical supplies including packaging, shipping and handling of drug products.
• Part of the optimisation and harmonization team of the Global SOPs for the clinical supply chain processes,
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2. and actively served as subject matter experts on QA strategies.
• Managed relationships with third party vendor for packaging, and successfully trained and gave
accountability to the vendor to undertake pre-inspections, resulting in reduced time to pre-release stage.
• Championed continuous improvements efforts, including analysis and review of quality attributes and
determination of Quality Improvement Parameters.
• Developed and conducted training for QA Associates, supply chain and other associated personnel.
• Compiled technical agreements formulation and negotiation with vendors and internal entities.
• Recognised need for investigation due to deviation from written procedures, conduct investigation into non-
conformance incidents/deviations and lead the closure of historical deviations that have historically
remained on this system following disagreements between different entities.
• Led Change control and Risk assessment management.
• Conducted performance annual and random audits, taking necessary action to eliminate risk as necessary.
• Grew the team to four staff from two, being qualified, high personal level, intelligent personnel (Master in
science or higher), with responsibility for training, performance and management.
Biotechnology General Apr 2011 to Dec 2012
Bio-Technology General (Israel) Ltd. is an integrated biopharmaceutical company, BTG has a diverse portfolio of therapeutic products
targeted at niche markets selling to over 40 markets.
GMP GROUP LEADER
• Developed interpreted and implemented quality policies, quality new systems, and facilitated regulatory
compliance to support manufacturing and QC testing of all commercial products and phase 2-3 production.
• Reviewed GMP quality metrics. Analysed data relating to process validations, process controls, and
continuous process improvement efforts. Presented KPI’s and reports to senior management.
• Oversaw the manufacturing of API to drug product and medical devices.
• Provided guidance, interpretation, support, training, and input on the interpretation of regulations,
guidelines, company procedures, and policies. Trained sterile filling personnel on how to dress, behave and
act in the sterile filling in order to eliminate environmental and product contamination.
• Shortened the batch records review by defining the critical parameters to check.
• Assisted in local and international regulatory inspections including FDA,
• Reduced environmental testing according to regulatory requirements and scientific reasoning.
• Oversaw the internal audit program with a focus on cGMP compliance and implementation of CAPA.
Recommended systems for audit, coordinated schedules and followed up corrective actions.
• Managed a team of 8 staff (at academic level) with multiple responsibilities including: Batch record review,
Aseptic processing oversight, manufacturing and QC deviations, investigation management and
multidisciplinary investigations and projects.
Biotechnology General Jan 2008 to Apr 2011
GMP ASSOCIATE
• Provided oversight on manufacturing and QC testing under the GMP requirements, and aligning quality
management strategy to support the release of final product.
• Supported a key project to mitigate risk relating to product disposition, identifying issues within the sterile
filing suite, resulting in environmental contaminations.
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3. • Managed all deviations and CAPAs handling.
• Controlled batch record reviews, and oversaw asptic processing.
Previous Positions Held:
• Technical Support
Orgenics, 2006 to 2007
• Laboratory Technician
Sheba Medical Center, 2001 to 2004
• Laboratory Technician
Weizmann Institute of Science, 2000 to 2001
ADDITIONAL SUPPORTING INFORMATION
Qualifications & Accreditations:
• Master of Science (MSc), Human/Medical Genetics
Tel Aviv University,2004
• Bachelor of Science (BSc), Animal Sciences
The Hebrew University, 2001
• High School Diploma, Mathematics and Physics
Haderah High School,1993
Publications:
• Tabori et al. Epidermal Growth Factor Receptor Gene Amplification and Expression in Disseminated Pediatric Low
Grade Gliomas. Journal of Neurosurgery (Pediatric 4) 103:357-361, 2005
Courses & Professional Studies
• Managerial Course
• CRA Qualification Course, PharmaJob
• ISO 9001(V 2008), ADL College
• Clean Room Design, Maintenance & Cleaning, Cleanroom Compliance, Inc
• Analysis and Characterization of Protein Therapeutic Drugs, BioForum
• RCA, Root Cause Analysis, Bioforum
• Fermentation Technology Principles and Practice, MLBC
• Capa and Product Lifecycle Approach, Bioforum
• Cleaning in Place (CIP) Technology Principles and Practice, MLBC
Full referee details can be supplied upon request
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