Experience

NOVELIC

• Serbia
• Embedded Software Products
• 100 - 200 Employee

• Quality Project Manager

  • Jan 2022 - Present

  • Support the creation of Quality processes as required in product development, preferably in embedded software and/or electronic HW for automotive applications. FMCW radar technology for ADAS. • Conducting the Automotive SPICE 3.1 processes and maintain compliance with ALM tool Code Beamer. • Conducting the ASPICE Assessment. Detecting non-compliance to automotive standards and procedures. Suggesting the Preventive and Corrective actions. Writing the Quality Assurance Plan on the projects • Requirements management. Establish exchange process with stakeholders (Tool, procedures, proof of exchange, etc.…). Analyse requirements, including safety, security and conformity requirements. Verification of the stakeholder requirements (completeness and acceptability). Writing System requirements Specification (development goal, map requirements function and features). Review system requirements (create baseline, release system requirements) • Review Architecture and Detail Design specification and Test strategy, Test cases, Integration and qualification activities. • Plan and coordinate functional safety activities. Ensure the compliance of SW Tools qualification and SW the product development process with ISO 26262 /IEC 61508. Lead and support the safety analysis (system FMEA, DFMEA, FTA, etc.). • Quality and documentation support in implementation of Industrial safety requirements ISO 13489, • Implementation of project management activities using (Jira, Confluence, GitLab) Show less



ZF Group

• Germany
• Motor Vehicle Manufacturing
• 700 & Above Employee

• Quality department Team Lead

  • Jan 2019 - Dec 2021

  IATF 16949:2016, • Leading Testing laboratory in production, leading persons, organization of activities, preparation of OpEx and CapEx budget plan (Investment plan), purchase activities of consumables and new equipment, implementation of method, preparation of VDA 6.3 Audits (internal, customer and systems), 5S , etc… • Implementation of IATF 16949 requirements through Laboratory procedures. • Support all stakeholders in Production and Development department in daily activities. • Implementation of Quality strategy and awareness in complete production chain departments from Design department, Logistic, Production, Production Planning and Maintenance. Change management from requirement to production site activities (like calibration activities, SPC, MSA, PFMEA analyse, Control plans, Pre acceptance and Line realise, etc …) Show less



STADA Group

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• HEAD OF CALIBRATION, QUALIFICATION AND VALIDATION DEPARTMENT

  • Jun 2006 - Dec 2018

  • Implementation of pharmaceutical regulations (cGMP EU and FDA-USA, TGA AUS), applicable procedures, guidelines, company policies and other quality or regulatory requirements. • Implementation of Computer System Life Cycle - executes/facilities gap analysis and/or risk assessments (FMEA) focus on function to ensure evaluation of current computer systems to ensure compliance with part 21 CFR Part 11, Annex 11 and GAMP 5, creation of CS inventory list, categorisation of software and implementation of validation life cycle – V cycle - according to GAMP 5 (URS, FS, DS, IQ, OQ, PQ) and creation of Traceability Matrix. From stand-alone software of instruments to the complex computer system like LIMS, SCADA or BMS. • Implementation of Data integrity policy in GMP context (ERES): Principe of ALCOA+, FDA static and dynamic data, Audit trail review strategy. • Review suppliers qualification/validation documentation (VP, FAT, SAT, IQ, OQ, PQ), as well as technical documentation (drawings, manuals, instructions etc.) and specifications (FS, SDS, HDS etc.) against user requirements, customer quality standards, procedures and guidelines. Team leader or member of the team for execution and supervision of the qualification/validation activities on the project in production (preparation line, autoclaves, tunnels, stability chambers) and laboratories instruments (incubators, owens, refrigeration) or computerized system validation. • Preparing and realization of annual plans (operation financial budget, staffs plan and purchase/investments plan for new reference equipment and IT equipment) of department. • SAP Key user for QM/PM modules - execution of functional and integration tests during upgrade systems and change controls. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Qualification Engineer

  • Dec 2006 - Dec 2006