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oracle

Associate General Manager, Project & Engineering

Amneal
Gujarat, IND
Full-time
Manager · 15–20 years experience
Onsite
Discovered 2 days ago
Communication

Full Job Posting

Qualifications

  • Education: B.E/ B. Tech (Mechanical/ Electrical/ Electronics/ Instrumentation)
  • 15 - 20 Years
  • Roles & Responsibilities
  • Responsible for the Plant Maintenance activity of DS (Drug Substance) section equipment's such as Fermenters, Process vessels, CIP vessels, batch centrifuges, TFF systems, Merck chromatography columns, Filter press.
  • Responsible for Maintaining of biologics MFG units (Cell Culture), Filling Facility (DP),Quality Control, Warehouse and R&D facility.
  • Maintenance of Biologics manufacturing facility (Mammalian) including Development and QC lab(Microbiology).
  • Responsible for QMS Documentation validation and new Equipment Qualification.
  • Bioreactor
  • Fermenter
  • Media, Buffer & CIP vessel
  • Continuous Centrifuge
  • Continues Kill system
  • Homogenizer
  • Chrome system
  • TFF system
  • Autoclave
  • Chromatography
  • The candidate should be from Biopharma industry having exposure Drug Substance and Drug product Maintenance.
  • The candidate should have exposure to regulatory Audits.
  • The candidate should be aware of GDP/ GMP Process.
  • The candidate should have exposure to new equipment qualification & QMS as well.
  • The candidate should have good communication skills.

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