Victorya Levenchuk
QA Specialist
Tel-Aviv
Summary
Dedicated QA specialist, professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
9
9
years of professional experience
3
3
years of post-secondary education
4
4
Certifications
3
3
Languages
Work History
QA-CMC Specialist
BiomX
Ness-Ziona
03.2021 - Current
- Implementation of quality assurance standards in the company to meet required quality level for clinical production of sterile and non sterile products, using aseptic manufacturing and packaging process.
- Planing and establishment of cleanrooms facilities In cooperation with engendering consultants.
- Planing, implementation and leading environmental and physical parameters monitoring of cleanrooms facility (grades A,B.C and D), including qualification of relevant personnel to perform EM.
- Planing and implementation of cleanrooms facility cleaning process and qualification of relevant personnel.
- Leading cooperation with CMC units to develop and evaluate DS and DP production process of two different products to meet all required quality aspects (Topical and IV indications).
- CCS (contamination control strategy) Risks assessment and evaluation based on new draft of Annex 1.
- Leading Process and impurities related Risk assessment based on process mapping of different projects.
- Management and Performance of Internal and External Audit Plan
- Writing, reviewing and approving of SOPs, Protocols, Methods and Batch records.
- Management and Performance of annual training (Including GMP, GDP, Data integrity, Deviation and OOS investigations, CAPA, CC, Behavior and gowning in cleanrooms. EM, Production using Aseptic Technics in cleanrooms).
- Equipment validation Protocols (IQ,OQ,PQ) and calibration reports review and approval.
- Management and Performance of Deviation and OOS investigations
- Management and Performance of CAPAs and Change Controls.
QA /QC Analyst
Tree of Life Pharma
Lod
01.2020 - 03.2021
- Ensure company compliance with ISO 9001, ISO 13485 and ISO 22716 standards.
- Preparing the company for ISO and Ministry of Health inspections, serving as SME (subject matter expert) and assessing the results to inform corrective action measures.
- Review and approval of SOPs, MBRs, CoAs and CoCs.
- commercials batches approval and release.
- Management of GXP related training matrix, and annual training performance
- management and documentation of client complaints
- vendors approval and evaluation
- performance of internal and external audits.
- Product stability management, stability reports writing, shelf life extensions.
- Performing IPC, release and stability laboratory tests for company products ( appearance, pH, conductivity, package integrity, viscosity, density, loss of dry, hardness,
- production and packaging lines opening and approval
- Raw materials testing and approval
- Equipment management including periodic maintenance and calibration.
Flight Attendant
El-AL Airlines
02.2014 - 12.2019
- Premium & business class stewardess- Inflight service for Luxury class passengers, including attendance in special flights (president, prime minister)
- Ensured safety, security, medical emergencies help and comfort of customers onboard aircraft.
- Verified aircraft and passenger compliance with policies, regulations and safety guidance.
Education
Associate of Science - B.Sc Life Science
Tel Aviv University
Tel-Aviv, Israel 10.2015 - 08.2018
Skills
Excellent social skills
undefinedCertification
Cleanrooms in Bio-pharmaceutical industries, By Eran Yona, Bioforum
general
* 2017-2018 Volunteer with honors at "Telfed"- South African Zionist Federation, Israel
Timeline
Contamination Control Strategy and Revised Annex 1- A Risk Based Approach to Management of Sterile Products
02-2022
Calibration and measurement principles caurs - M.B.A.
01-2022
Internal Audit inspectors course -by SII (standards Institution of Israel)
12-2021
QA-CMC Specialist
BiomX
03.2021 - Current
Cleanrooms in Bio-pharmaceutical industries, By Eran Yona, Bioforum
03-2021
QA /QC Analyst
Tree of Life Pharma
01.2020 - 03.2021
Associate of Science - B.Sc Life Science
Tel Aviv University
10.2015 - 08.2018
Flight Attendant
El-AL Airlines
02.2014 - 12.2019
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