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Manager Engineer

Location:
Sydney, NSW, Australia
Posted:
February 02, 2013

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Resume:

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

[pic]

Tertiary:

La Trobe University

1992 to 02/1988 - Full Bachelor Of

Time Science (Honours) in Applied Mathematics

Employment History

[pic]

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

[pic]

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

[pic]

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

[pic]

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

[pic]

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



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