Հրապարակվել է: 06.07.2018
· 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..
· 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.