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Manufacturing Quality Management System

3 months ago

Bengaluru, India Biocon Biologics Full time

Qualification: BE/B.Tech/M.Tech/ M.Sc in Microbiology/Biochemistry/Biotechnology

Experience: 8+ years


Responsibilities:

  • Overall QMS responsibility of manufacturing operations and facility management.
  • Ensure compliance (GMP, GXP) with appropriate SOP’s as per regulated market requirements
  • Ensure compliance with appropriate SOP’s, policies and guidelines for operations in manufacturing plant
  • Monitor performance metrics, draw conclusions, and make recommendations in the manufacturing review meeting (MRM) forum
  • Identifying compliance issues and product quality issues and championing solutions
  • To Identify risks and escalate them to the department head and relevant functional heads.
  • Identifying needs for performance improvement and interacting with users and training departments
  • Responsible for identification of repeat and overdue QMS events and ensure proper CAPA is in place to stop such events
  • To review all , Protocols and other closure reports and ensure they comply to regulatory audits.