László Erzsébet Nikolett

Use, supervision of the operation and participation in the development of the LIMS information system; Checking and defining LIMS methods, uploading specifications; Verification and validation of LIMS calculation engines; documentation of tests according to GMP regulations.

Notification of inappropriate (OOS) results, investigation, PQR, trend preparation, control of laboratory measurements. Introduction of the LIMS application and its connection to the SAP system. Use of the TrackWise system, initiation and management of deviations and procedure changes.

Stability group: Writing and checking protocols and reports,Incident Report and Change Control in the TrackWise system management, Product Quality Review (PQR) control, Stability Creating and checking CARDs, using the iCube system,maintaining contact with other Mylan sites and external partners.

Department of organic chemistry: performing HPLC tests to determine target components food, environmental from air, water, soil, other materials, method developments,follow-up of professional literature,Method development department: performing GC-MS tests to determine target components food, environmental from air, water, soil, other materials, method developments,follow-up of professional literature.

• Raw material and finished product purity control by HPLC device, according to GMP rules.