Maiia Sydorenko
Leading Auditor for Quality System at YURiA-PHARM LLC- Claim this Profile
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English Full professional proficiency
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Ukrainian Native or bilingual proficiency
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Russian Native or bilingual proficiency
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German Elementary proficiency
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Bio
Nataliia Surzhko
Maiia did a great job growing as a regulatory compliance specialist. She is highly focused person and can add to any team she is a part of. She is organized, diligent and a fast learner. Maiia started as a quality engineer and grow into senior responsible for auditing and GMP compliance combining different pharmaceutical regulations. So I definitely recommend Maiia and be sure of independent and highly qualified specialist be present in your team to achieve the best!
Nataliia Surzhko
Maiia did a great job growing as a regulatory compliance specialist. She is highly focused person and can add to any team she is a part of. She is organized, diligent and a fast learner. Maiia started as a quality engineer and grow into senior responsible for auditing and GMP compliance combining different pharmaceutical regulations. So I definitely recommend Maiia and be sure of independent and highly qualified specialist be present in your team to achieve the best!
Nataliia Surzhko
Maiia did a great job growing as a regulatory compliance specialist. She is highly focused person and can add to any team she is a part of. She is organized, diligent and a fast learner. Maiia started as a quality engineer and grow into senior responsible for auditing and GMP compliance combining different pharmaceutical regulations. So I definitely recommend Maiia and be sure of independent and highly qualified specialist be present in your team to achieve the best!
Nataliia Surzhko
Maiia did a great job growing as a regulatory compliance specialist. She is highly focused person and can add to any team she is a part of. She is organized, diligent and a fast learner. Maiia started as a quality engineer and grow into senior responsible for auditing and GMP compliance combining different pharmaceutical regulations. So I definitely recommend Maiia and be sure of independent and highly qualified specialist be present in your team to achieve the best!
Experience
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YURiA-PHARM LLC
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Ukraine
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Leading Auditor for Quality System
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2020 - Present
Manages and improves quality assurance processes in accordance with international regulatory requirements and coordinates the work of teams of specialists in the areas of licensing and QMS of medicines, CAPA processes, internal audits/audits of suppliers• Analyzes the results of the teamwork of specialists in quality control sector and prepares reports• Develops new QMS processes, analyzes and improves existing QMS processes• Develops training materials and conducts personnel training in accordance with applicable regulatory requirements• Monitors changes in regulatory requirements, develops plans to prepare the company for the implementation of new regulatory requirements• Prepares the company for international inspections, participates in inspections and develops CAPA• Coordinates and participates in Internal / Suppliers Audits. Participates as a Lead Auditor
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Auditor for Quality System
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2018 - 2020
Ensuring the process of licensing and certification, analysis, and audits to confirm the compliance of the quality system and products (own production and import) to international regulatory requirements• Plans and conducts of internal / supplier audits• Develops CAPA, and participates in the development of measures to prevent non-compliance after audits• Provides regulatory support for the quality management system processes for medical devices/medicines / imported products• Develops new QMS documents
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Certification Specialist
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2017 - 2018
• Update QMS documents and/or Technical files and their accompanying documents for medical devices; Organizes approval and agreement of print materials for MD• Develops legal documents• Investigates complaints/recalls about imported products• Participates in risk assessment of medical devices• Perform certification process for import products. Contact with regulatory Bodies
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Quality Specialist
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2013 - 2017
• Perform testing medicines by indicator «invisible mechanical inclusions» on laboratory equipment • Sampling for stability tests and transfer them to the laboratories
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Education
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2015 - 2018
National University of Pharmacy
Master's degree, Quality, standardization and Certification -
2013 - 2015
Bohdan Khmelnytsky National University of Cherkasy
Bachelor's degree, Accounting and Audit -
2010 - 2013
Commercial college
Bachelor's degree, Accounting
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