Quality Specialist

Ոլորտ: Առողջապահություն

Քաղաք: Երևան

Հրապարակվել է: 05.12.2018

Վերջնաժամկետ: 18.01.2019

Main Duties:

·     Collaborate with Principle Investigator, R&D Manager and QA/QC Manager to ensure GCP compliance of Clinical part in Bioequivalence studies.

·         Ensure new and existing personnel are adequately trained in the proper performance of their assigned tasks.

·         Develop validation protocols and reports.

·         Perform analysis of deviations.

·         Perform/participate in Quality Management System audits and Study design

·         Manage CAPA, Deviation, OOS and Audit programs.

·         Participate in Quality management reviews.

·         Collaborate with QM to contribute to proper documentation system.

·         Perform compliance review on the following records: Study protocol, Data analysis, Study Report, etc..

Required qualifications:

·   Master’s degree in Medicine, Pharmacy, Biochemistry, Chemistry, or other related          field

·      At least 3 years of experience in a similar position either in clinics or in laboratory

·      Strong knowledge of GCP, GMP, GDP and other relevant regulations

·      Excellent knowledge of Armenian, Russian and English languages

·      Strong computer skills (MS Office)

·      Excellent communication and presentation skills

·      High sense of responsibility

·      Detail oriented

·      Ability to effectively work in a team

·      Ability to multitask.

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