Anna Vershinina Email & Phone Number

Yokohama, Kanagawa, Jp

A short-term IT outsourcing project in an AI Merchandising E-commerce company.Achievements: - Appointed to a team lead position and onboarded new team members.- Developed metrics for AI search testing.- Analyzed options and proposed a new test management system, which resolved a critical workflow blocker.Responsibilities:- Gathered and analyzed requirements- Prepared technical documentation- Tested AI search functionality- Localized defects at the UI, backend, database, and AI search module levels

Achievements: - Led the implementation of a new system for converting regulatory dossiers into XML format; tested the system as a final user, conducted a series of training sessions for two teams, and troubleshot errors in cooperation with the vendor's support service. - Helped 2 manufacturing sites improve documentation and product release processes for 5 countries, which enhanced the overall process and prevented findings during audits.- Developed a strategy to rework documentation under the new legislation, including drug specification and test methods description, labeling information, and patient instructions, which allowed the company to receive the first approval under the new procedure.- Arranged and held a series of lectures for my colleagues from 3 different countries on implementing new regulatory legislation with which they had no practical experience.- Created opportunities for the business by analyzing the documentation of 2 products and suggesting new claims that could be used in advertising.- Managed up to 10 projects simultaneously. Responsibilities: - Maintained regulatory dossiers for 9 Nurofen brand products.- Prepared dossiers for new registrations.- Tracked regulatory quality incidents in the quality management system.- Conducted documentation analysis.- Prepared and checked normative documents, patient information leaflets, SmPCs, and packaging materials.- Created change control records.- Maintained product information in PLM systems.- Provided regulatory support for GMP audits.- Collaborated with Marketing, QA & QC, NPI, Planning and Logistics teams.- Planned budgets.- Analyzed and selected counterparties.

Achievements: - Implemented and tested a new regulatory dossier management system as a final user.- Achieved a 97% approval rate for regulatory submissions.- Onboarded and trained 2 new team members.- Successfully coordinated up to 12 projects simultaneously.- Grew from novice responsibilities to handling advanced regulatory procedures in less than a year.Responsibilities: - Maintained existing regulatory dossiers.- Prepared dossiers for upgrades.- Operated software for dossier storage and XML conversion.- Conducted documentation analysis.- Prepared and checked normative documents and packaging materials.- Interacted with regulatory authorities on medicinal and veterinary products.- Coordinated intermediary companies submissions.

Quality Assurance Engineering

Achievements: 1. Current GPA: 97/100. 2. Successfully passed the entrance exams (only 1 in 5 applicants accepted into the course).

Master'S Degree, Pharmaceutical Sciences

Achievements: 1. Led the School of Mastery of 10 students. 2. GPA: 4.6/5