AM/Dy. Manager

3 days ago

Gangtok Rangpo, India Zuventus Healthcare Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities

  • Overall responsible for QA activities.
  • Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments.
  • To review and Approval / Reject the Quality Management System documents such as change control, deviation, CAPA, laboratory and production failures investigation, OOS, market complaints, product recall etc.
  • To review and approve risk assessments.
  • To perform self-inspection.
  • To review and approved /Reject QMS documents.
  • To prepare, review and approve the apex documents such as Site Master File, Validation Master plan and Departmental manual.
  • Release of finished product to market.

Preferred candidate profile

  • Having around 15 years of experience in QA in OSD.
  • Having audit exposure of PIC/S, EU GMP.
  • Having exposure of handling team.
  • Age between yrs

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