VP QA/QC

Ness Ziona · Full-time

About The Position

• To promote overall quality goals and achievements across the company and educate on QA and QC principles.

• To develop, establish, implement and maintain the QA/QC management systems

• To oversee development and implementation of standards, methods and procedures for evaluating the precision, accuracy, efficacy and reliability of critical processes

• To follow in-house GMP manufacturing and managing all related QC/QA activities 

• To lay down procedures for the preparation, approval, authorization, control and revision of SOPs 

• To review and edit company SOPs

• To assure appropriate documentation per product stage

• To audit all critical IND-enabling studies and reports

Requirements

• Bachelor's Degree or higher within the Life Sciences space

• 5+ years of experience within a quality role in a biologics focused environment

• Experience in establishing stage specific quality systems for R&D research, pre-clinical and clinical stages

• Experience in GMP manufacturing activities as review of batch records, OOS, CAPA, etc.

• Experience in execution of analytical methods qualification and GMP stability studies

• Broad knowledge of drug development

• Expertise in GMP; strong working knowledge of FDA & EU and ICH regulations in relation to the manufacturing of biologics

• Participation in preparation of applications to regulatory authorities

• Attention to detail

• Excellent written English skills

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