Erion ÇINA

** ******** ******, *** **, Yonkers NY, 10704

Email: acxj25@r.postjobfree.com

Cellphone: 914-***-****

PROFILE

Pharmaceutical expert in production and quality assurance issues.

** ***** *f experience in managing the biggest pharmaceutical production facility in Albania.

Experience on SOPs writing, cleaning validations, machine qualifications, process validation and quality products review. Production director for a long time.

Able to construct quality policy for company following the guidelines of EU GMP and ICH Quality.

Qualified Person for Batch Release.

PROFESSIONAL EXPERIENCE

04/ 2001 – 08/ 2016 PROFARMA sh.a. Tirana Albania, ( www.profarma.al part of Dermapharm AG, www.dermapharm.de until 09.2013)

Technical Director and Head of Quality Assurance

Writing company policies and systems for pharmaceutical manufacturing and quality assurance following the guidelines of EU GMP and ICH Quality.

Qualified Person for Batch Release: responsible for approval or rejection of starting material, drugs component, primary and secondary packaging, finished products.

Leading Quality Assurance and Validation team for cleaning validations, machine qualifications, process validation and quality products review. Determining optimal organizational structure and work flow.

Writing products quality reviews

Planning, coordination and control of all manufacturing processes.

Ensuring that all change that potentially could impact product quality are documented

Ensure that the production records and testing results are complete, accurate and documented according written procedures.

Conducting internal and external client audits.

Purchase department supervisor

Part of a big team in planning and construction of a new pharmaceutical plant from 2009 until 2011

04/ 2006 – 06 / 2016 University of TIRANA, Faculty of Medicine, Department of Pharmacy

Lecturer of Practice in Pharmaceutical Production

Teaching the subject of pharmaceutical practice in production to the fifth ( final ) year pharmacy students at faculty of medicine

10/ 2011 – 06 / 2012 Albanian University, Department of Pharmacy

Leading the laboratory work of Pharmaceutical Technology

Leading the laboratory classes of pharmaceutical technology for galenic’s preparations

09/ 2006 – 09 / 2013 Government Health Insurance (www.fsdksh.com.al)

Executive board member

Decision maker for health insurance policy in Albania

TRAININGS

Milano, Italy 18-20 May 2011 – Colorcon Coating School

MIBE GmbH Arzneimittel, Brehna, Germany - January 2012- Quality Assurance for pharmaceutical production facilities.

MIBE GmbH Arzneimittel, Brehna, Germany - January 2013 – IT ( ERP ) system for pharmaceutical production ( ScaraPLUS )

Attendance at 5th Trial Master File Summit, Seminar and Workshop in Arlington, Virginia- 20-22 January 2016

EDUCATION

2007- 2008 Post university Studies, Master in

Faculty of Medicine, Department of Pharmacy,

University of Tirana Albania

1996–2001 Bachelor of Science degree in Chemistry (Pharmacy)

Faculty of Medicine, University of Tirana

1992 -1996 High School, Bab Dud Karbunara, Berat, Albania

SKILLS

Microsoft Office, Word, Excel, PowerPoint, ScarabPLUS

Languages: English ( fluent ), Italian ( fluent ), Albanian ( native )

REFERENCES

Dr. Hans-Georg Feldmeier

General Manager

mibe GmbH Arzneimittel

Ein Unternehmen der Dermapharm Gruppe

Münchener Straße 15

D - 06796 Brehna

acxj25@r.postjobfree.com

www.mibe.de

Tel: + 49 (0)34954 / 247 – 105

Mob:+49-173-*******

Fax: + 49 (0)34954 / 247 - 100

Rechtsform: GmbH

Sitz der Gesellschaft: Brehna

Amtsgericht Stendal: HRB 16 486

Geschäftsführer: Wilhelm Beier, Dr. Hans-Georg Feldmeier

Mrs. Xhovana DOSHI

General Manager

Profarma SH.A.

Rruga Myslym Keta

Tirana, Albania

www.profarma.al

Mob: +355-**-***-****

acxj25@r.postjobfree.com

acxj25@r.postjobfree.com

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