emanuel tomić

e-ctd specialist

Country

croatia

City

croatia

Industry

electrical/electronic manufacturing

Skill

matlab, power systems, electrical engineering, calibration, equipment qualification, regulatory affairs, pharmaceutical industry, sap, microsoft office, electronic common technical document, nees, adobe acrobat pro, laboratory, srs/tact, glorya edms, adam edms, wisdom edms, sage edms, psur, global insight, ectdxpress

Experience

publishing professional, regulatory submission management

pliva hrvatska d.o.o.

2017-7 - Present · 9 yrs 3 mos

* Publishing of registration dossier in eCTD, NeeS and paper format * Validation and electronic distribution registration dossiers inside TEVA Group and towards authorities * Maintaining database of electronic dossiers * Make sure that all publishing/dispatching/archiving steps are done on time with required quality * Help/support other team’s members to finish their tasks on time, if/when needed

laboratory equipment maintenance engineer

pliva hrvatska d.o.o.

2014-9 - 2017-7 · 2 yrs 11 mos

* Qualification of laboratory equipment (DQ, IQ, OQ and PQ) * Maintenance of laboratory equipment (PM and corrective) * Participation in resolving laboratories deviation * Participating in the establishment standards like GLP, GMP * Reconciliation of computer systems with the requirements of 21 CFR part 11

instrument calibration associate

pliva hrvatska d.o.o.

2013-4 - 2014-9 · 1 yr 6 mos

* Calibration of temperature and humidity sensors and transmitters, pressure sensors and transmitters, calibration of time meters (clock gauges) (in calibration laboratory, analytical laboratories and production line) * Working with pressure weights and other etalone equipment (electrical standards, pressure standards, humidity and temperature standards)