RESUME
Personal Details Of Con Tzouroutis
Address: ** ********** ******,
Kellyville NSW 2155 Australia
Home Phone Number: +61 2 8824 5316
Work Phone Number: +61 2 9978 3537
Mobile Phone +61 4 2294 8454
Number:
Email abn7uk@r.postjobfree.com
(professional):
Email (private): abn7uk@r.postjobfree.com
Date of Birth: 16/12/1967
Nationality: Australia
Career Objective: Validation Project Lead /Manager for a
growing Pharmaceutical Multinational Co. and
International Placements.
Other Languages: Greek
References: Available on request
Education
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Tertiary:
La Trobe University
1992 to 02/1988 - Full Bachelor Of
Time Science (Honours) in Applied Mathematics
Employment History
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April 2011 to current - Full Time: Validation Team Leader /
Project Lead & Revalidation
Position: AstraZeneca North Ryde,
Australia
Company Description: Manufacturer of
Pharmaceutical Products
(Sterile)
Duties: Revalidation Team Leader:
Manage all revalidation site
activities. Includes
programs for
Steam Sterilisers, Various
Cycles/Loads
SIP BFS, F&F Holding Tanks
Cleaning Validation CIP
Dry Heat Steriliser,
Budesonide Funnels
Filters, Component Prep
Out of Spec Investigations
Change Control, CAPA
Validation Project Lead:
Provide management and
leadership for the
commissioning and validation
of new projects. Activities
include:
Risk Assessments PURS, PIA
Review URS, FS, DDS
Qualification Plans QP (DQ)
for new Packing Line
Equipment, Systems.
Validation Plans, OQ
Protocols
Manage and Lead Validation
OQ activities for
Finishing Line
Nikka Leak Detector
Fuji Flow Wrapper
Packing Line
Serial Product Tracking
Equipment Systems (SPT)
Validation Lead for BFS Line
Relocations in Q4-2011
Computer System Validation
activities.
September 2010 to March 2011 - Full AstraZeneca Wuxi, China
Time:
Position: Project Leader /Validation
Company Description: Manufacturer of
Pharmaceutical Products
(Solid Dose)
Duties: Validation of two Tablet
Coaters during Technical
Transfer and Scale-Up.
Activities included
completion:
IQ/OQ/PQ
New auto-Coating Cycles for
Wuxi Ops
Cleaning Validation CV
Process Validation
Training & Development
Completed handover of
Plendil, Imdur and Seroquel
from UK Ops.
August 2009 to August 2010 - Full AstraZeneca North Ryde,
Time: Australia
Position: Revalidation Team Leader
Company Description: Manufacturer of
Pharmaceutical Products
(Sterile)
Duties: Manage all revalidation site
activities.
September 2007 to July 2010 - Full AstraZeneca North Ryde,
Time: Australia (Sterile)
Position: Validation Engineer
Company Description: Manufacturer of
Pharmaceutical Products
Duties: Validation assignments as
required by the Employer,
for example
SOPs
Change Control, CAPA
Uhlmann Blister Machine
OQ/PQ for new Autoclave
Cycles (SBM Rototherms).
June 2007 to September 2007 - Full PharmOut Pty Ltd
Time:
Position: Validation Consultant
Company Description: Human Resources agency
specializing in placements
for the Pharmaceutical
Industry
Reporting To: Director, Trevor Schoerie
Duties: Validation assignments as
required by the Employer
February 2007 to June 2007 - Fixed AstraZeneca Pty Ltd for
Term (F/T): PharmOut Pty Ltd
Position: Validation Engineer /
Contractor
Company Description: Manufacturer of
Pharmaceutical Products
Reporting To: Validation Manager
Duties: Completed validation of two
Getinge Autoclaves for the
new Microbiology Laboratory.
This involved:
Development of new cycles to
meet User Requirements.
Developed suitable load
configurations for OQ and
PQ.
Completion of OQ/PQ
Protocols.
Performed Validation work
using a GE Validator 2000 as
per the protocols.
Compiled report with
sign-off and associated
folder with attachments for
each protocol undertaken.
September 2005 to February 2007 - Cabways Pty Ltd
Full Time:
Position: Taxi Operator / Driver
Company Description: Taxi Operation, Training &
Development
Reporting To: N/A
Duties: Driver
July 2005 to August 2005 - Full GSK Boronia / Zektin Group
Time:
Position: QA / Validation Officer
Company Description: Manufacturers of
Pharmaceutical Products
Reporting To: Operational Quality
Validation Manager
Duties: Assisted with planning and
execution of validation
tasks as requested by the
Validation Manager.
Reviewed VMP, DQ and IQ
Completed OQ/PQ Protocols
and Reports.
1999 to September 2005 - Full Time: C Taxi Pty Ltd
Position: Self Employed - Small
Business Owner (f/t)
Company Description: Taxi Operation
Reporting To: N/A
Duties: Running a taxi business
ensuring that it remained
profitable and viable.
Responsible for the day to
day management of drivers,
collation of data and fleet
maintenance.
1995 to January 2002 - Full Time: CSL Limited - Bioplasma
(Broadmeadows)
Position: Validation Officer
Company Description: Manufacturers of bioplasma
products
Reporting to: Validation Manager
Duties: Planning and performance of
validation requirements for
processes, capital works
projects and routine
monitoring. This involved:
Writing Validation
Protocols, Methods and
Standard Operating
Procedures (SOP's)
Process Validation (PV)
Monitoring equipment/product
via the PMCS
Trending Data MS Excel
Writing Validation Reports
Performing Environmental
Monitoring and Validation
of Autoclaves in Bottle
Preparation, Packaging and
R&D
Performing System Checks in
Dispensing
OQ for the CIP plants
Monitoring of water plants
PFWC, PFWH and WDI
Monitoring of SIP and
Compressed Air
1994 to June 1995 - Full Time Employed by Labstaff to CSL
Bioplasma for contract work
Position: Validation Assistant
Company Description: Manufacturers of bioplasma
products
Reporting to: Albumin Manager
Duties: I was involved in the
validation of the Buffer
plant, Albumin plant and
CSL's Albumin products. This
involved:
Auditing commissioning
documents
Collecting and submitting
samples
Documenting trials
Analysing data (tables &
charts)
Writing Reports
Assisting with the
development of Routine
Validation documents
Skills and Expertise
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GMP High Level, 10+ Years
Validation IQ/OQ/PQ High Level, 10+ Years
Process Validation High Level, 10+ Years
MS Windows, MS Office Expert (Constant Use)
Technical Writing High Level, 10+ Years
Change Control / CAPA 5 Years
Aseptic Processing / SIP / BFS 5 Years
Blow Fill Seal (BFS) 3 Years
Terminal Sterilisation / Autoclave High Level, 10+ Years
Validation
Packing Line Equipment 3 Years
Vision Systems 2 Years
Cleaning Validation (CV) 3 Years
Computer System Validation 2 Years
Quality Auditing 5 Years, TGA
Team Leader 3 Years
Knowledge
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Current use of PIC/s PE 009-10
PDA Technical Report No. 1 Validation of
Moist Heat Sterilization Processes:
Cycle Design, Development, Qualification
and Ongoing Control Rev. 2007
PDA Technical Report No. 29, Points to
Consider for Cleaning Validation (1998)
ICH Q8, Pharmaceutical Development
ICH Q9, Quality Risk Management
ICH Q10, Pharmaceutical Quality System
ISO/EN 17765, Sterilization of health
care products - Moist heat - Part 1:
Requirements for the development,
validation and routine control of a
sterilization process for medical
devices
ISO 2859-1:1999 Sampling Procedures for
Inspection by Attributes
Hobbies and Other Interests
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Travelling, Investing, History, Famous People, R&D Science,
Applied Mathematics, New Technology, Soccer / Football
Awards
[pic]
Comalco Bursary Awarded to the most outstanding student
in Applied Mathematics III enrolling in
Applied Mathematics IV, 1990
Third Year Downing Prize Awarded to the most outstanding student
in Physics in third year Physics within the school
of Physical Science, 1990
Referees
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Professional: Trevor Schoerie
Director
PharmOut Pty Ltd
Contact: Phone: (03) 86 400 933
Mobile: 042*-***-***
Email: abn7uk@r.postjobfree.com
Professional: John Petteno
Quality Systems & Validation Manager
AstraZeneca Pty Ltd
Contact: Phone:
Mobile:
Email:
Professional: Joe Gangi
Managing Director
Zektin Group
Contact: Phone: (03) 8480 1000
Mobile: 040*-***-***
Email: abn7uk@r.postjobfree.com
Professional: Tony McEntee
General Manager
North Suburban Taxis P/L
Contact: Phone: (03) 9480 0377
Mobile: 041*-***-***
Email: abn7uk@r.postjobfree.com
Professional: Norm Chealle
(former QC Validation Manager at CSL
Bioplasma)
Senior Consultant
PharmOut Pty Ltd
Contact: Phone:
Mobile: 043*-***-***
Email: abn7uk@r.postjobfree.com