1. page 1 July 2015
CONTACT:
Mail: joksimoviczeljko@gmail.com
Phone (+)381 64 12 707 59
http://rs.linkedin.com/pub/zeljko-joksimovic-m-sc-mee/5/50a/22/
Personalia
MARKET EXPERIENCE  Technical support for equipmentqualification 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
Picture
CV Zeljko Joksimovic
Independent Expert Associatefor
Equipment validation

2. page 2 July 2015
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
Equipmentqualification engineer / Qualification of production and
laboratory equipment and systems
PERIOD March 2008 – Present

3. page 3 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

4. page 4 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