Alexandra Mizhiritsky
Vaughan,ON
Summary
I am a dedicated and highly skilled professional with a B.Sc. in Biotechnology Engineering from Ben Gurion University and an MBA from the College of Management, where I received a certificate of excellence. At my last position I was serving as the Quality Systems Manager at Omrix (Johnson & Johnson MedTech), I have a proven track record in developing and maintaining robust quality management systems, leading a team of 15 employees in developing and maintaining the company's QMS ensuring compliance with ISO 13485, ISO 9001 and FDA Requirements, resulting in successful regulatory audits and improved quality standards. My extensive experience includes managing non-conformance and CAPA processes, risk management, document control, and serving as a key participant in regulatory audits. Fluent in English, Hebrew, and Russian, I bring a comprehensive skill set in quality assurance, data integrity, and continuous improvement, poised to excel in the role of Quality fields.
Overview
13
13
years of professional experience
Work History
Quality Systems Manager
Omrix (Johnson and Johnson MedTech)
01.2023 - 03.2025
- Develop and maintain the company's quality management system (QMS) in accordance with relevant regulations and standards, such as ISO 13485, ISO 9001 and FDA requirements.
- Responsibility of the following functions: NC/CAPA, Risk Management Processes (pFMEAs), Document Control, Statistics and stability, Labeling, Computer system Validations (total department of 15 employees).
- Monitor and assess the effectiveness of the QMS through regular audits, inspections, and reviews.
- Serving as a Host during external regulatory audit (Israeli Minister of Health).
- Participate in regulatory inspections and audits, ensuring compliance with regulatory authorities' requirements. Serving as a support team during Audits performing roles of Back room, Scribe, Reviewer, Back Room Manager.
- Identify areas for improvement and implement corrective and preventive actions (CAPAs) to address non-conformances or deviations from established quality standards.
- Taking an active part at local and Global communities such as: WLI, Credo team, Digital Quality Council, Academy relations and taking part at volunteering activities at the community.
QA-IT CSV Lead
Omrix (Johnson and Johnson MedTech)
07.2019 - 07.2023
- Supervises the daily activities of the CSV Engineers. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Trains, plans, schedules and assigns work, appraises performance and resolves problems.
- Provides guidance and oversees complex investigations to close out validation discrepancies / exceptional conditions, Non conformances and CAPAs related to CSV aspects. Participates in or leads resolution of compliance issues of varying complexity. Ensures appropriate resolution and documented justification.
- Assesses and manages compliance risks, escalating to management as necessary.
- Participates in regulatory audits as technical expert for CSV validation packages. Ensures validation activities are consistent with applicable regulatory requirements and appropriately conveyed to regulatory bodies via associated regulatory submissions.
- Leading the Data Integrity all Omrix Champions Team during 2018-2019 (2 years).
- Full Support during internal and external audits (Including 3 Weeks FDA on site audit, MDC, Health ministry etc).
- Serving as a support team during Audits performing roles of Back room, Scribe, Reviewer.
Senior CSV engineer
Omrix (Johnson and Johnson Med Tech)
01.2018 - 07.2019
- Plan, lead and perform computer system validation activities according to the latest regulations (CFR part 11, GAMP 5, data integrity etc.) across all Biosurgery sites for business applications and QC laboratories, Engineering control systems (HMI) and production manufacturing systems.
- Computerized systems Data Integrity SME.
- Develops, implements and maintains validation policies, procedures, templates and supports a culture of continuous improvement.
- Thorough knowledge of GMPs related to validations as well as FDA and EU regulatory requirements for biologics and combination products.
- Assist and advise on CSV aspects for internal and external projects. Support at CSV projects for Neuchatel site at Switzerland.
- Taking Part at audits to external suppliers as an SME for computerized quality aspects.
CSV engineer
Omrix (Johnson and Johnson)
01.2016 - 12.2017
- Plan, lead and perform computer system validation activities for business applications and QC laboratories, Engineering control systems (HMI) and production manufacturing systems. This included writing and execution of: IQ/OQ protocols, writing of reports, SOPs according to GDP principles all based on the latest regulations (CFR part 11, GAMP 5, data integrity etc.)
- Performance of nonconformance investigations, CAPAs. Performance of change controls.
- Leading the Data integrity at computerized system project, focus on QC laboratory, Production department and IT systems. The project included performance of gap assessment and implementation of mitigation processes based on DI regulatory requirements (MHRA, CFR, PIC/s).
R&D researcher
Pharmaseed LTD
01.2014 - 12.2015
- Company Overview: CRO company
- Performance of CRO projects including performance of pre-clinical, in-vivo studies using analytical instruments. Working at GLP environment.
- Responsible for the management and procurement for the Anatomy department. The position included collaborations with local and international costumers and providers.
- CRO company
QA – Student Position
Periggo Israel
08.2012 - 10.2013
- Performance of QA verifications on the packaging process at GMP environment including trainings to employees.
Education
B.Sc - Biotechnology Engineering
Ben Gurion University
01.2013
MBA - Management
College of Management
01.2024
Skills
- MS Office
- ADAPTIVE
- TrackWise
- WindChill
- Clearquest
- Qtest
- SAP R3
- ERP Priority
- IRIS
- Root-cause analysis
- Power BI
- Document control
- Python
- Risk mitigation
- CAPA management
- Change control
- Quality metrics
- Validation techniques
- Preventive actions
- Continuous process improvement
- Corrective actions
- Quality management system compliance
- Validation master planning
- GMP auditing
- Trackwise
- Quality processes
Languages
English
Hebrew
Russian
Spanish
Interests
At my free time I love to paint with oil colors and swim
Timeline
Quality Systems Manager
Omrix (Johnson and Johnson MedTech)
01.2023 - 03.2025
QA-IT CSV Lead
Omrix (Johnson and Johnson MedTech)
07.2019 - 07.2023
Senior CSV engineer
Omrix (Johnson and Johnson Med Tech)
01.2018 - 07.2019
CSV engineer
Omrix (Johnson and Johnson)
01.2016 - 12.2017
R&D researcher
Pharmaseed LTD
01.2014 - 12.2015
QA – Student Position
Periggo Israel
08.2012 - 10.2013
MBA - Management
College of Management
B.Sc - Biotechnology Engineering
Ben Gurion University
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