1. October 14th
, 2016, Athens, Greece
Dear Sir/Madam,
My name is Yiannis Vidalis and with this current letter I would like to provide some additional
information about my experience:
During running my Diploma degree in Chemical Engineering I was able to get deep knowledge of the
laboratories analytical equipment such as HPLCs, GCs, ICP, AAS, UV-Vis spectrometers additionally to
basic lab equipment. Complex math calculation and statistical process of data were part of daily routine
at the university, giving me therefore the opportunity to increase MsExcel in an advanced level. In
parallel writing and presenting exercises increased my MsWord and MsPowerPoint skills.
During running my Master’s Degree in Delft University of Technology I was able to further practice my
English language oral and writing skills as the whole studying program was given in English. Furthermore
I had the opportunity to work and to get familiarize with engineering designs for water treatment. Costs
and efficiency calculations was part of the main internship in the Netherlands.
Further on, during working in Australia I was able to improve my skills in literature review, experimental
design, experimental work, data interpretation, conclusion extracting, and writing protocols. Even more,
I was mentoring Bachelor students. Daily practice of English language improved further my
communication skills. Upon the end of my original thesis I was glad to publish for one of the most
important journals in the field of Membrane Science.
I have been working for pharmaceutical companies since November 2010, always in sterile
manufacturing.
1. DEMO S.A. (November 2010 – January 2014) / FDA project. In further details, the project was about
Dry Sterile Powder Filling Process concerning pharmaceutical product for the U.S. market (FDA project).
During that period I was able to review, apply and practice of FDA regulations in manufacturing process.
I was assigned Quality Assurance Validation Officer and I faced the great opportunity to deal with all
designing and constructing stages, especially regarding qualification aspects (Qualification Level
Assessment / FAT review / SAT review / IQ / OQ / PQ / Qualification Reports / Requalification SOPs
preparation / PV / Requalification Activities). Furthermore, I repeatedly prepared qualification protocols
and reports. I was also specialized in using KAYE Validator (preparing and running qualification runs for
Incubation Equipment, Steam Sterilization and Dry Oven Sterilization processes). I was also specialized in
PPW, PW and WFI water system qualification ( thus I have significant knowledge on water systems
microflora), HVAV units qualification and data processing.
I assigned with additional duties from May 2012 to May 2013 I was able to work in parallel with
qualification activities, in the Compliance section of the Dry Sterile Filling Project, make me involved and
prepared D.I.R.s, Change Controls, FollowUps, C.A.P.A. plans and further improve my good
documentation practices and current good manufacturing practices. I had also the opportunity to be
audited by external authorities and customers during the same period regarding this project and to get
familiar with handling of raw materials, APIs, primary and secondary packaging materials and final
product warehouses in terms of qualification and SOPs preparation making me strongly familiarized with
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2. GDPs. In that respect I participated several audits in external services providers such transportation
companies and logistics services.
2. FAMAR (February 2014 – now) In FAMAR, Alimos Plant I appointed as Manager for Quality Systems.
This position holds responsibilities in SOPs & CAPAs handling, VMP and equipment / software
qualification activities, Receipt of Customers and Authorities Audit, Suppliers Evaluation and Complaints
Handling (including Audits to suppliers, participating so far in four, mainly in primary packaging materials
and -irradiation), Training and documents review. Within this frame I had a great opportunity to work in
a really competitive environment which demands fast responses to customers always in accordance with
GMP regulations. I have the responsibility of introducing cGMPs into the Quality System and annually
train personnel as well. I have also been trained for Batch records review. I got further familiar with
classified areas cleaning and sanitization processes and HVAC system qualification. Having the
opportunity of facing three shut down procedures in the factory, I got experience in shut down and start
up processes and scheduling in a short time manner.
I keep myself up to date in GMPs and requirements by participating in seminars.
Within the frame of qualification responsibilities all these years I was able to get familiar with CSV in
many different aspects and levels. Starting in DEMO pharmaceuticals as a QA validation officer in an FDA
project I had the opportunity to get familiar with 21 Code of Federal Regulation, part 11 and Annex 11.
GAMP 5 Quality categorization and respective risk approach was part of daily life when dealing with
systems qualification such as HMIs, SCADA systems, PLCs, software for EMS, Software for KAYE Validator
etc. During the same period I was able to assess authorization levels and to work in several ways in data
integrity. In parallel, I had the responsibility of MSExcel spreadsheet qualification. While in
pharmaceutical industry I work regularly in co-operation with IT department organizing tests from the
quality and regulatory point of view. Within that process I got familiar with logic diagrams and I am able
to understand basics in source codes. Especially while working with SCADA system I got experience in
HMIs and PLCs parametrization/customization. Currently, as a Quality Systems Manager I have the
responsibility of planning all validation activities, (including CSV activities for the plant). I had the
opportunity to work in new projects for new software installation such as EMS and I participated in the
team while updating SAP (ERP) system, risk assessments, test design and execution in the plant. I am
also familiar issuing URSs for CSV. Moreover I have participated in several OQ execution teams while
checking alarms triggering in HMIs, PLCs, SCADAs and software systems. From my position I am
responsible for issuing thus the VMP including CSV activities, reviewing any CSV protocol and report for
the plant and participating the team of approving tests results.
I keep myself up to date also in CSV by participating in respective seminars.
I would like to inform you that I would be at your disposal in case of any additional information is
required. I would also like to thank you in advance for your time.
Sincerely yours,
Yiannis Vidalis
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