Assistant Manager – Validation (Injectables) | Zydus Hospira | Ahmedabad

Manufacturing, QA/QC/QMS/IPQA/CQA
Gujarat
May 1, 2023
Full Time
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Job Overview

  • Date Posted
    May 1, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    August 13, 2024
  • Experience
    7 Years, 9 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree

Job Description

Handling of QMS system:

  • Change control
  • Deviation
  • CAPA
  • Audit compliance

Process and cleaning validation:

  • PV/CLV planning and communication with cross-functional team
  • NPI/NPL assessment
  • Dossier review
  • Addressing regulatory query
  • PV strategy preparation
  • Process Validation Master Plan & Cleaning validation master plan preparation
  • Filter validation assessment
  • MACO/LOD/LOQ calculation
  • Worst-case identification for CLV in case of new product introduction
  • Review of Technology transfer document/ surface compatibility report
  • Preparation of PV/CLV protocol and report
  • Audit handling
  • In detail depth knowledge of CLV

Equipment Qualification:

  • Tunnel, Mfg. Vessels, filling machine,
  • Smoke study protocol/report preparation and review

Utility qualification

  • Water system
  • Compressed air system
  • Nitrogen system
  • HVAC system

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