Working on Regulatory and Quality computerized systems / applications:- Calyx Insight Publisher- Calyx Insight Manager- Lorenz docuBridge- Lorenz drugTrack- Sparta Systems TrackWise- Labware LIMS- ServiceNow Quality ForwardMain responsibilities:- IT project manager • Project planning • Stakeholder management • Team leadership • Resource management • Risk management • Budget management • Documentation and reporting • Validation testing • Communication and vendor management • Post-implementation hyper care- IT Application owner • Application operation, support and management • Continuous improvement of assigned applications • Monitoring and ensuring service delivery and operations within defined Service Level Agreements (SLA) • Resolution of incidents, tickets and issues • Maintaining lifecycle management and applications roadmap • Regular governance meetings with business • OPEX and CAPEX budget management • Audit participation and support • Documentation creation (validation, SOPs and WIs) • Training of secondary owners and/or business admins

Coordination of OpEx improvement projects in Quality Control

Main responsibilities:- Introducing Lean Lab in Hemofarm- Coordination of OpEx improvement projects in Quality Control- Leading and coordinating team of 16 employees (process leaders, expert associates and technicians)- Managing centralized laboratory support activities (consumables procurement, standards, samples, placebos and HPLC colums management)- Sampling, AQL and visual inspection management- KPI implementation and reporting- Yearly investment and budget plan for Quality Control

Main responsibilities:- Implementation of 5 modules of MasterControl quality electronic system (Issue Review, Deviation, Nonconformance, Complaints and CAPA)- Quality on the shop floor in laboratory (laboratory quality officer)- Coordination of deviations and nonconformances- Participation in root cause investigations related to OOS/OOT- Proscribing corrective and preventive measures (CAPAs) and follow-up on CAPA implementation and effectiveness- Establishment of risk analysis to assess the impact of nonconformances on product quality- KPI reporting

Main responsibilities:- Leads and coordinates investigation of deviations for nonsterile products- Exploring new regulatory requirements and implementing them (GMP, USP, EMEA, guides for sterile production)- Cooperation with other organizational units on daily basis (Production, Quality Control, Purchasing, Marketing, Registrations) and contractual partners- Yearly budget/financial planning

Main responsibilities:- Collecting and submitting regulatory documents for IVD medical devices- Registration of new medical devices on Serbian market- Communication with local regulatory Agency and keeping medical devices' dossier up to date- Communication with CMOsAdditional duties and achievements:- Creation and review of relevant SOPs regarding Quality and Regulatory Affairs- Participation in ISO 13485 regulatory inspection

Main responsibilities:- Leads and coordinates investigation of deviations for nonsterile products- Exploring new regulatory requirements and implementing them (GMP, USP, EMEA, guides for sterile production)- Cooperation with other organizational units on daily basis (Production, Quality Control, Purchasing, Marketing, Registrations) and contractual partners- Yearly budget/financial planning

Working on:- Planning, organizing, implementing and monitoring activities related to the implementation of GMP requirements- Managing the continous GMP training for employees, Change Control system and implementation of periodic reviews of product quality (PQR)- Keeping training records and checking the compliance of documentation related to Quality Assurance- Proposing measures to improve the process of GMP compliance and Quality System Service- Planning, designing and introducing KPIs- Yearly budget/financial planning