Cigdem AKDEMIR AKGUN

*** ****** ***** ****, ** **513

Cell Phone: 516-***-****

adc1ra@r.postjobfree.com www.linkedin.com/pub/cigdem-akdemir/76/129/22b/ SUMMARY

More than 17 years laboratory experience, with commended performance conducting/analyzing laboratory assays, wet chemistry accordance with standard operation procedures, Working knowledge of GMPs, ICH guidelines and Pharmacopeia (USP/NF and EP) methods Serv ed as sophisticated laboratory analytical equipment operator (HPLC, UPLC). Configuring and validating LIMS and related data systems for QC (cGMP), Involved in accreditation studies according to ISO 17025 and ISO 9001. Experience in lab practices/techniques (pipetting, weighing, preparation of samples, solutions and reagents). Ability to work around and/or with hazardous materials and chemicals generally found in a laboratory environment. EXPERIENCE

Instrument Qualification Tech (NNE Inc. Contractor) 07/22/2019-02/11/2020

Novo Nordisk, Clayton, NC

Writing and executing qualification and/or validation protocols and reports

Involved in qualification of laboratory instruments (IQ/OQ/PQ) and USP <1058>

Working with FTIR, Karl Fischer, Auto titrator and Density Meter.

Using electronic (paperless) systems to write and execute protocol

Presenting technical information to others.

QC Raw Materials Chemist II, 10/16/2017-05/10/19

Akorn Pharmaceutical Inc, Amityville, NY

Quality Control tests for raw materials by High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectrometry (FTIR) ATR and KBr, UV Spectrometer, Karl Fischer, Moisture Analyzer, Polarimeter, Rotational Viscometer, Densitometer, Melting Point Analyzer, Osmometer

Performing wet chemistry, i.e. titrations, heavy metals test, Arsenic, Mercury, Lead, Selenium tests, loss on drying, residue on ignition viscosity, thin layer chromatography, assay of raw materials, related compounds etc. accordance with standard operation procedures, USP/NF and cGMP.

Preparation of test solutions and preparation and standardization of volumetric solutions

Maintenance and updating all records and lab books as well as training records; presented results to stakeholders and drafted reports.

QC Scientist II, 03//16/2017- 09/15/2017

Amneal Pharmaceutical LLC. Hauppauge, NY

Quality Control tests for raw materials by High Performance Liquid Chromatography

(HPLC), Fourier Transform Infrared Spectrometry (FTIR), Karl Fischer.

Performing wet chemistry, i.e. titrations, heavy metals test, Arsenic, Mercury, Lead, Selenium tests, loss on drying, residue on ignition viscosity, thin layer chromatography, assay of raw materials, related compounds etc. accordance with standard operation procedures, USP/NF and cGMP.

Performing packaging materials tests i.e. description, identification, measurements Quality Control Scientist, 10/5/2015-03/11/2017

Sciegen Pharmaceuticals Inc-Hauppauge, NY

Performing calibration, maintenance and routine sample analysis of the laboratory equipment like pH meter, UV spectrophotometer, Dissolution unit, Karl Fisher titrator, HPLC, FTIR

Provide well written and thorough reports in timely manner

Maintenance of lab documents according to GLP guidelines, current USP and filled up log files regularly and kept it up to date

Performing routine testing, blend testing,in process material, finished products testing such as assay, content uniformity, blend uniformity, composite assay, impurity, disintegration, identification by UV and FTIR, water by KF, Partical Size Distribution, angle of repose, bulk and tapped density, loss on drying and other tests

Maintained proper documentation of laboratory data, complete testing, data evaluation, and LIMS reporting

Evaluation of stability of ANDA batches, process validation and commercial product

Tracking and maintenance of all laboratory documents, reports as per GDP Implement cGMP,

Implement cGMP, USFDA and ICH guidelines in routine laboratory practices. Quality System Supervisor

March 2009 to June 2012

Ankara University Biotechnology Institute-Ankara, Turkey

Creation of technical and research documents such as method development and validation

procedures, SOP's, infrastructure projects proposals, laboratory quality manuals etc..

Developing effective working relations with groups, individuals, agencies and the public.

Administered procurement of supplies and supervised technical staff.

Training of personnel on laboratory functions.

Senior Biologist

May 2001to February 2009

Ministry of Food and Agriculture -Ankara, Turkey

Performing studies to achieve sample analysis by sophisticated equipment (HPLC, UPLC, LCMS).

Analyzing of food materials such as dried fruit, dairy products, food additives, three nuts contaminated with natural toxins such as mycotoxins.

Involved in accreditation studies according to ISO 17025

Performing studies to achieve food safety research objectives.

Administered health risk assessment studies including exposure assessment.

Created technical and research documents such as food safety control reports, validation reports.

EDUCATION

Ph.D., Pharmaceutical Toxicology 2008

Ankara University Pharmacy School-Ankara, Turkey

Master of Science: Biochemistry 2001

Ankara University Veterinary Faculty Ankara, Turkey Bachelor of Science: Biology 1988

Dicle University Science Faculty Diyarbakir, Turkey COMPUTER SKILLS AND COMPETENCES

Microsoft Office 2010 Specialist Certifications (Word, Excel, Power Points, Outlook)

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