לוח אפשרויות קריירה - הדרך החכמה להייטק

a global biotech company is looking for QA CMC specialist
Responsible for QA activities in the company including CMC, pre clinic, bioassay and clinical QA


DUTIES
To implement standards, methods and procedures in CMC processes
To follow in-house and external GMP manufacturing and support all related QA activities
Determine the requirements for documentation, materials, training, equipment.
To review and approve production batch records, Batch release
To lay down procedures for the preparation, approval, authorization, control and revision of SOPs
Responsible for training and implementation of SOPs
To maintain environmental monitoring tracking and trending, perform internal investigation in case of deviation.
Lead investigations related to Manufacture process / Equipment, CAPA’s, Change Control.
Review and approve calibration, IQ, OQ, PQ reports.
Review submission documents to ensure organization, clarity, accuracy, format and consistency.

דרישות:

Bachelor's Degree or higher within the Life Sciences space
2+ years of experience within a quality role in a biologics focused environment
Experience in GMP manufacturing activities as review of batch records, OOS, CAPA, etc.
Expertise in GMP. strong working knowledge of FDA & EU and ICH regulations in relation to the manufacturing of biologics – an advantage
Participation in preparation of applications to regulatory authorities – an advantage
Excellent written English skills