Dmitrij Viatkine

GMP manufacturing site with production of aseptic and sterile products.

Main Responsibilities :

• Maintenance and management of the following QC's/physical lab instruments: "Agilent" UV-VIS, "Wescor" vapor pressure osmometer, "Metrohm" pH-meter, "Orion" pH-meter, "Ecolog" data loggers for temperature monitoring, "Chatillion" material tester, "HIAC 9703+" particle counter, "Anton Paar" polarimeter and medical refrigerators/freezers. "MAXIMO" (eMMS) is used for documentation of maintenance and management of all instruments.
• Assist in validation of new instruments according to GAMP.
• Assist in validation of new methods according to ICH.
• Ensure compliance according to Pharmacopeia for different countries/regions and ISO guidelines.
• Perform risk assessments.
• Training of new/existing personnel.
• Creation and update of instrument SOP's
• Review and elaboration of GxP documentation. All GxP documentation should be compliant with ICH guidelines, pharmacopoeia, ALCOA+.
• Improvement of data integrity according to ALCOA+.
• Experience with writing Product Quality Reports, periodic review reports, Global and local SOP.
• Review of validation documentation
• Management of deviations and CAPA with help of TrackWise (eQMS).
• Participating in Audits, for instance from FDA, EU, and Japan
• Help to create LIMS based forms for reporting.
• Close cooperation with the health and safety department on numerous topics like Chemical Waste Management, ATEX zones, wastewater release, and different types of incidents.

Projects I have been on within my current role.

• Member of a team that was responsible for validation and verification of new production tanks.

Additional knowledge that I gained over several years of working on site with aseptic and sterile production:

• Understanding of how pharmaceutical HVAC systems work.
• Understanding of how pharmaceutical water for injection is produced.
• Understanding of how pharmaceutical clean steam is produced.

Responsibilities:

• Quality control of X-ray and MRI products according to international GMP standards with following techniques: HPLC, ICP-OES, ICP-MS,UV-VIS, freezing point and vapor pressure osmolality, pH measurment, titration, refractive index measurment, polarimetry, particle counting and several material testing techniques on packaging that is used to store the products.
• In-process analyses.
• Results reporting in LIMS and assistants with creation of new LIMS templates.
• Waste water control for contamination on HPLC and ICP-OES. Performed according to government's EHS (Environment, health and safety) guidelines and specifications .

Worked as a sales assistant at a KIWI supermarket.

Worked at Siemens as part of my thesis project. I was responsible for Installation of PLCs, PLC programming, installation and configuration of other electrical components. Project was used to display latest technology Siemens had to offer at the time to their customers.