Крістіна

Kristina Makhovska
Date of birth: 06 Aug 1991 (32 y.o),
Address: Kyiv, Ukraine
Tel.: [открыть контакты](см. выше в блоке «контактная информация»)
E-mail: [открыть контакты](см. выше в блоке «контактная информация»)

Work Experience

Pharmacovigilance • Processing of reports about undesirable events and notifying SEC
Specialist about them;
Jun 2023 – present time • preparation and submission of PSURs to the SEC;
• submission of an application and dossier for company’s products
Servier Ukraine, Kyiv, about changing the frequency and/or terms of submission of PSURs
Ukraine according to the procedure V.I.10;
• literature searching;
• trainings for partners;
• business correspondence.

Quality Specialist • approving of certificate templates with foreign manufacturers,
Nov 2022 – Feb 2023 verification of certificates for compliance with EU regulations;
• reviewing SOPs;
Astrazeneca Ukraine, • business correspondence with foreign manufacturers.
Kyiv, Ukraine

Quality Specialist • working with complaints, patients (investigations, communication
Mar 2020 – Nov 2022 with the manufacturer, providing a response);
• working with deviations (investigations, CAPA)
ACINO UKRAINE LLC, • implementing of an electronic document management system in the
Kyiv, Ukraine Company. Training of 46 employees of the department. Writing
instructions for using the system;
• implementing modules in TrackWise, writing instruction for using;
• approving of certificate templates with foreign manufacturers,
verification of certificates for compliance with EU regulations;
• initial training for new employees of the company;
• signing TQA with suppliers, manufacturers;
• writing and reviewing SOPs;
• business correspondence with foreign manufacturers;
• working with contracts.

Clinical pharmacist, • participating in clinical trials of oncological drugs.
deputy head of • Working with medicines:
pharmacy, Kyiv, Ukraine ➢ incoming control,
➢ keeping protocols,
Aug 2018 - Jan 2020 ➢ filling out documents,
➢ diluting them and issuing them to patients in accordance with
 GCP rules;
➢ monitoring the storage of medicines in the departments of the
clinic;
➢ keeping a journal with the prescriptions of the State Service.
Dealing with recalled products.
• Maintaining 10 protocols. Interactions with monitors.
• ordering medicines for using by clinic, medical products for
operations and patient care in the postoperative period.
• formatting of receipts for patients, preliminary calculation.
• conducting inventories.

Quality specialist of the • Organization of work in accordance with GDP requirements.
pharmacy warehouse, • Conducting audits of suppliers - the presence of licenses, QMS,
assistant of the Senior SOPs;
Quality specialist, Kyiv, • incoming quality control of products;
Ukraine • documentation of acceptance of goods:
➢ maintaining registers of incoming control,
Apr 2017 - Sep 2017 ➢ acts of acceptance and non-conformities,
Pharmaco LLC
➢ logs upon receipt of goods from the supplier,
➢ processing and archiving of primary documents for delivery;
• recalling of products from the market;
• controlling of storage conditions, expiration dates, sanitary regime
in the warehouse, keeping temperature logs of premises, refrigerators
and freezers. Presenting at sanitation of vehicles and their inspection
every day before leaving for clients, filling in journals on sanitation.
Granting permission to release products from the warehouse.
Replacement of dec. funds quarterly.
• staff training;
• working with CAPA;
• organization of work (contracts, agreements) with an outsourcing
company - rodent control, disinsection, cleaning services;
• making changes to the SOPs;
• checking of observance of a cold chain by suppliers, measurement
of temperature.

Pharmacist of the • Validation and qualification of premises, vehicles, refrigeration
pharmacy warehouse, equipment, thermal containers.
Kyiv, Ukraine • Writing protocols of the validation and qualification, reports, data
collection, recording temperatures;
Feb 2016 - Feb 2017
BaDM LLC • logging journal of subject-quantitative accounting, leave and
accounting, inventory;
• incoming control of medicines, checking compliance with the cold
chain, maintaining registers;
• staff training;
• recalling, quarantine, returning to the supplier or destructing under
Ukrainian legislation;
• controlling of storage conditions, expiration dates, sanitary regime
in the warehouse, keeping logs.

Controller of medical • Controlling of the collected medicines with their further packing.
products, Kyiv, Ukraine
Sep 2009 - Feb 2016
BaDM LLC

Education

2021 Ukrainian Military Medical Academy
ORGANIZATION AND Retraining
ECONOMICS OF
PHARMACY
Kyiv, Ukraine

2015-2016 Shupyk National Medical Academy of Postgraduate Education
General Pharmacy awarded the title of pharmacist
Kyiv, Ukraine

2009-2015 National Medical University of O. Bogomolets
Pharmacy Diploma specialist is equivalent to Diploma Master in Ukraine
Kyiv, Ukraine after changing education law in 2017

Language

Ukrainian – Native
Russian - Native
English – Upper-intermediate
German - Beginner

Trainings

Trainings in a sphere Quality Managment system (Kyiv, Ukraine)

2019 Good Clinical Practice (GCP). Regulatory regulation of conduct in clinical
trials
10.07.2020 Processes for investigating deviations and inconsistencies in the functioning
of the pharmaceutical quality system (PQS). Corrective and preventive
actions. Practical algorithms for building effective systems for dealing with
deviations and inconsistencies

24-25.09.2020 Good Distribution Practice: Basic Course

24-25.09.2020 GDP rules and PQS principles, basic course - Outsourcing management and
audit system based on PQS principles - requirements and approaches for
their practical implementation, the main highlights of the inspection
assessment

29.09.2020 Deviation/inconsistency management, change management, theory and
application

19.11.2020 Typical errors when working with deviations and (or) inconsistencies

27.11.2020 Good practice for the storage and transportation of medicines. WHO rules
14-15.12.2020 GDP rules and PQS principles, basic course - key processes of a
pharmaceutical company's quality system - requirements and approaches for
their practical implementation, main focuses in the inspection assessment

15.12.2020 New GMP/GDP Trends in Paper Documents and Records Management

13.01.2021 Risk Analysis in Change Control with Examples

19.01.2021 Rules for the preparation and approval of supplier audit reports

09.02.2021 Distributor quality system in accordance with GDP

16.04.2021 GDP Course: GDP Requirements for Outsourcing. Technical (Quality)
agreement

19-20.08.2021 Assessing a distributor's compliance with GDP: self-diagnosis checklist. The
inspector's view

15.09.2023 Basic course of Pharmacovigilance