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وظائف شاغرة للعمل لدى شركة الحكمة للأدوية .


إعلان توظيف صادر عن شركة أدوية الحكمة. 



فرص عمل لدى شركة الحكمة للأدوية 


مطلوب موظفين للعمل لدى شركة أدوية ( الحكمة). 

AR Supervisor (Extractable & Leachable). 


Job Description

Responsible for analytical method development for extractable and leachable testing by GC-FID-MS, LC-UV-MS.

Responsible for structural elucidation for unknown extractable, leachables, and other unknowns in drug products.

Responsible for developing semi-quantitative and quantitative chromatographic and mass spectrometric methods for extractable and leachables.

Responsible for assisting other laboratories on method development, optimization, validation and trouble shooting.

Generates documents in support of regulatory submissions.

Effectively communicates in technical documents or at team meetings. Participates in cross departmental project teams as required.


Skills

Must have significant knowledge and experience with mass spectrometry: LC-MS, GC-FID/MS and HPLC. Experience with ICP-MS is a big plus.

Has a working knowledge of quantitation using mass spectrometry.

Has a working knowledge of structural elucidation using mass spectrometry.

Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements is highly desired.

Understanding of industry guidance provided by the FDA, ICH and USP relating to extractables and leachables.

Understand of the industry guidance provided by regulatory agencies on nitrosamines. 


Education

PhD or master's degree in analytical chemistry or closely related field


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