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Associate General Manager, Project & Engineering

Overview
Amneal Pharmaceuticalsamneal.comPosted 10 days ago
Ahmedabad, Gujarat, INOn-site
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Seniority level
Executive
Employment type
Full time
Work experience
15 to 20 years
Specialization
Executive leadership

About the role

We are looking for Process Equipment Lead with B. E/ B. Tech Degree with 15- 20 Years of experience for our Biosimilar R&D facility Based out of Ahmedabad. Below are the further details.

Experience15 - 20 Years

Education: B.E/ B. Tech (Mechanical/ Electrical/ Electronics/ Instrumentation)

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.

Key skills

  • Quality Control

Required Instruments Exposure

  • Bioreactor
  • Fermenter
  • Media, Buffer & CIP vessel
  • Continuous Centrifuge
  • Continues Kill system
  • Homogenizer
  • Chrome system
  • TFF system
  • Autoclave
  • Chromatography

Candidate Details

  • 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 newequipment qualification & QMS as well.
  • The candidate should have good communication skills.