Engineer Training

Curriculum Vitae

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Vadim Shyrobokov

Personal information:

Born: November 21st, 1988 at Kiev (Ukraine), 29 years Citizenship: Ukrainian

Address: Kiev, Ukraine

Marital status: Single

E-мail: *****.**********@*****.***

LinkedIn: https://www.linkedin.com/in/vadim-shyrobokov/ Skype: ordinary00

Mobile phone: +38-093-***-**-** (Viber&WhatsApp available) Objectives:

Obtain a job that will allow me to not only apply my knowledge and skills to serve the company goal, but also deepen them and learn new things.

Job applied for: Validation engineer.

Professional skills:

Development and implementation of validation IQ/OQ/PQ protocols and reports for pharmaceutical equipment and engineering systems (clean rooms, HVAC systems, water systems PW&WFI, clean utilities) for sterile and non sterile sites.

Validation of autoclaves, sterilization tunnels, freeze dryers, packaging lines, tablet coating machines, tablet press and other equipment which is commonly used in pharmaceutical manufacturing

(including primary and secondary validation activities).

Validation of moist heat sterilization processes, dry heat sterilization.

Validation of warehouses.

Validation of systems of independent monitoring of parameters of the air environment.

Performing the calibration of instruments of the equipment.

Schedule adherence and execution planning and reporting.

Evaluation and analysis of validation documentation and technical documentation for compliance with FDA, cGMP, GAMP, ISPE and ISO guidelines.

Defining of the scope of the qualification activities and the list of required validation tests for a specific object of validation.

Conducting FAT & SAT.

Strong knowledge of the requirements of international regulatory documents and guidelines regarding to validation activities, as well as requirements in the pharmaceutical industry.

Negotiation and business correspondence with suppliers of the equipment and engineering systems (English language), concerning technical and validation documentation. Defending the interests of the Company.

Present and defend validation documentation during regulatory agency audits.

Training of staff involved in validation activities. Work experience:

Company: PJSC SIC “Borshchahivskiy Chemical Pharmaceutical Plant” (BCPP), Kiev, Ukraine Position: Lead validation engineer

Dates (from - to): 11.2011 - present

Education and training:

National University of Food Technologies (Kiev, Ukraine), 2006-2011 yrs. Complete higher education on specialty «Equipment for Pharmaceutical and Microbiological Industries». Specialist's degree.

Curriculum Vitae

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Courses:

Date Company Description

21.04.2017 GM Pharmaceuticals Ltd Seminar “Temperature mapping of storage areas” 06.12.2016 LLC Novations & Particle

Measuring Systems

Seminar “Revison to Parts 1 and 2 - ISO 14644-1:2015 и Air Particle Counter Calibration according to ISO 21501” 04.10.2016 VIALEK Group Seminar “New EU GMP requirements: Commissioning and Qualification”

13.11.2015 VIALEK Group Training course “Inspection of validation activities” 18.07.2015 STERILINE Srl Training course “Isolators & hydrogen peroxide vapour generator”

30.06.2015 VIALEK Group

Seminar “Analysis of the new edition of Appendix 15 of the European GMP Rules”

15.06.2015 KORSCH Training course “Tablet Press XL 200. Operation, Maintenance and Qualification”

09.10.2014 MARCHESINI GROUP Training course “Operation, maintenance and qualification Sterile Powder Filling Line”

10.12.2013 STILMAS (Manufacturer

of Pharmaceutical Water

Treatment Equipment

and Systems)

Training course “Purified Water. Production, Storage & Distribution System. Operation, Maintenance and

Qualification”

Training course “Water for Injections. Production, Storage & Distribution System. Operation, Maintenance and

Qualification”

24.10.2013 RT-Reinraumtechnik

GmbH (Design and

Execution of Clean Room

Systems)

Training course “Building automation systems (HVAC)”

(sterile site)

21.03.2013 FAVEA Training course “Thermal sterilization and validation” 18.07.2012 RT-Reinraumtechnik

GmbH

Training course “Building automation systems (HVAC)”

(non sterile site)

Foreign languages and other skills:

Languages: Ukrainian – native language;

Russian – native language;

English – advanced level (verbal and technical writing skills).

Additional: - A confident user of the PC and the MS Office program package.

- Skills of work in specialized programs: TQSoft, QAD Enterprise Applications, AutoCAD. Additional information:

Professional attributes: Attention to details, the ability to correctly prioritize the work process, organization skills, initiative.

Personal attributes: Responsibility, fast learner, sociability.

Interests: Active rest (snowboarding, cycling, running), self education.

In addition: - Valid international biometric passport.

- International driver's license (Category A and В).

- Available for relocation.

Contact this candidate