QA CMC - Specialist

  • Ness Ziona
  • Full-time

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about this position

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.

Requirements

  • 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

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