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Analytical Method Validation Specialist

Genveon İlaç Sanayi ve Ticaret A.Ş.

Kocaeli

İş Yerinde

İş Yerinde

Job Type

Full-Time

Position Level

Specialist

Department

Quality

Quality

Application Count

0-50 application

Job Type

Full-Time

Position Level

Specialist

Application Count

0-50 application

Department

Quality

Kariyer Image

QUALIFICATIONS AND JOB DESCRIPTION

We are looking for a Analytical Method Validation Specialist that will be responsible from the following processes:

•Ensure Health Authority requirements concerning the AS&T Department are fully met.

•Execute the main activities according to prepared SOPs and laboratory rules.

•Fulfill the responsibilities, which are given by leaders at the right time and correctly in conformance with methods, procedures and work flow.

•Following the global analytical method development studies, current guidelines and pharmacopeia.

•Routinely assess testing monographs and proactively sustain compliance of all activities with current official regulations, pharmacopeias, QM, QD, GOP and SOP.

•Evaluate and implement new technologies required to maintain state-of-the- art analytical methods for development and marketed products.

•Execute analytical method development, pre-validation and validation studies.

•Ensure right first time in all analysis and documentation.

•Prepare the related CTD documents of updated testing monograph.


QUALIFICATIONS 

•University degree in Pharmacy, Chemical Engineering or Chemistry
•Minimum 2 years of Analytical Laboratory experience with equipments e.g. HPLC, GC, UV/Vis 
•Knowledge of cGMP& cGLP and basic SAP
•Ability to work in a fast-paced changing environment
•Team working and customer oriented mindset
•Good analytical thinking skills
•Strong interpersonal written and verbal communication skills
•Good knowledge of MS Office applications
•Good command of English is required
•No military obligation for male candidates

Preferred Candidate

More than 2 years of experience
Bachelor’s(Graduate), Master’s(Graduate)
Completed
English(Reading : Advanced, Writing : Advanced, Speaking : Advanced)

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Şirketin Aydınlatma Metni

GENVEON İLAÇ ADAYLARA YÖNELİK AYDINLATMA METNİGenveon İlaç Sanayi ve Ticaret A.Ş. (“Şirketimiz” veya

Detaylı Bilgi

Kalite Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Kalite Uzmanı Kalite Uzmanı Maaşları Kalite Uzmanı Nasıl Olunur? Kalite Uzmanı Nedir? Kalite Uzmanı İş İlanları