CONTACT:Mail: joksimoviczeljko@gmail.comPhone (+)381 64 12 707 59http://rs.linkedin.com/pub/zeljko-joksimovic-m-sc-mee/5/50a/22/

Personalia

MARKET EXPERIENCE

Technical support for equipment qualification and process validation activities

Generation and execution of validation Protocols, specifically in IQ/OQ/PQ validation and routine re-qualification

Leading investigations and implementing corrective and preventative actions

DOB / NATIONALITY

19 May 1976 / Serbian

PLACE OF RESIDENCE

Vrsac, Serbia

EDUCATION Sep 2000 – July 2005: MSc in Industrial Engineering, University of Belgrade, Serbia

Sep 1995 – July 1998: BSc in Mechanical Engineering, University of Belgrade, Serbia

TECHNICAL SKILLS Hardware: Kaye Validator, Ellab data loggers, Vaisala Veriteq data loggers, ED data loggers, Kaye HTR, Kaye LTR, Yokogawa acquisition system, Ahlborn Al memo system

Software: Kaye Validator software, Ellab ValSuite, Veriteq software, Microsoft Office

LANGUAGE SKILLS English – fluent German – basic Serbian, Croatian, Bosnian – native

page 1 July 2015

CV Zeljko JoksimovicIndependent Expert Associate for Equipment validation

CV Zeljko Joksimovic

Experience

2005 – 2008 Private lessons to students from the subjects Hydraulics and pneumatics, Mechanical engineering technology and Machine materials/ Volunteering at the local center for preparing future students for entry testing for University

Market experience ORGANISATION / MARKET

Hemofarm Stada, Vrsac, Serbia /Member of Stada Arzneimittel AG Group, Bad Vibel, Germany

ROLE /PROJECT

Equipment qualification engineer / Qualification of production and laboratory equipment and systems

PERIOD March 2008 – Present

page 2 July 2015

CV Zeljko Joksimovic

APPLIED EXPERTISE • Team Leader and QA representative in teams for validation of

equipment and systems (production and laboratory equipment)•Expert for validation of sterilization processes•Generation and execution of validation Protocols, specifically in IQ/OQ/PQ validation and routine re-qualification of production equipment•Commissioning and Qualification of equipment and utilities•Review of supplier documentation and validation documentation•Presentation of validation activities to GMP audits and inspections (FDA (SME – Subject Metter Expert), TGA, SGS, Regierungspräsidium Darmstadt, Sachsen-Anhalt)• Training and coaching technicians and associates in quality management and qualification/validation activities • Performing Root Cause Analysis and defining corrective actions during qualification/requalification • Member of teams for change controls• Creation and review of qualification/validation documentation (Validation Master Plans, Validation Plans, Qualification Protocols, Qualification Reports) for devices and systems in manufacturing plants and laboratories (autoclaves, tunnels, chambers, freeze dryers...)• Creation and review of SOPs and guidance documents for device/system qualification and computerized system validation• Sterilization process Qualification and cycle development of Autoclaves Depyrogenation Tunnel Sterilisers, Depyrogenation Ovens, SIP Vessels, Freeze dryers. • Using Kaye Validator (V2K) and data loggers for O.Q & P.Q Validation (Thermal Mapping & data analysis)• Preparing following documentation as Annually Review (PQR) of Qualification/Validation Status• Management and control of the technicians performing the tests and assessment results•Good working knowledge of cGMP, ISPE Baseline Guides, PDA TR1,3,48,61 & EN285, ISO17665 and other pharmaceutical regulatory requirements •FMEA (Failure Mode and Effect Analysis) Rysk based approach for determination of critical processes and operation (GAMP, ISPE) •Implementations of CAPAs regarding Validation activities•Validation of systems as PW, WFI, N2, CoA

page 3 July 2015

CV Zeljko Joksimovic

Additional Info

TRAINING November 2009: European Computer Driving Licence (certification)

November 2012: NSF-DBA Good Autoclave Practice (certification)

March 2012: NSF-DBA Aseptic Manufacture and Good Aseptic Practice (certification)

October 2012: Regulatory Compliance Associates- Gowning and Cleanroom behaviour (certification)

October 2012: - Regulatory Compliance Associates - Managing Deviation Investigations (certification)

March 2013: Yellow belt Lean Six Sigma (certification) June 2014:Training and discution on FDA interactions

in preparation for inspection November 2014: Understanding sterilization process,

Complience and validation Services

Notice:all these trainings and courses were certified

PUBLICATIONS

10 Things to Consider When It Comes to Qualifying Autoclaves, May 27, 2013

http://www.askaboutvalidation.com/53175-10-things-to-consider-when-it-comes-to-qualifying-autoclaves

Short guide how to impress US and EU regulatory when the topic is steam sterilization

https://www.linkedin.com/pulse/20140626091649-16191386-does-bugs-lie-short-guide-how-to-impress-us-and-eu-regulatory-when-the-topic-is-steam-sterilization?trk=prof-post

page 4 July 2015