Assistant General Manager / Senior Manager - Mfg QMS Injectable

15 - 22 years

20 - 30 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Work Mode

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Job Type

Full Time

Job Description

Role & responsibilities

  • Leading a team of production QMS members
  • Responsible for preparation & review of the master documents of sterile manufacturing department and warehouse department for Parenteral facility.
  • Responsible for preparation and review of Protocols and reports based on the requirements.
  • Responsible for Document management like BMRs, BPRs, Master SOPs etc..
  • Responsible for the handling (Preparation/Initiation/Execution and Approval) of Change Control, Deviations, CAPA, Investigation, QRM, Protocol, Purchase specification etc.. for sterile manufacturing department & warehouse department.
  • Responsible for the Review and Approval of CFTs Change Control, Deviations, Investigation, QRM, Protocol, other documents etc..
  • Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same.
  • Responsible to give training to all the subordinates, technicians, and operators of the department.

Preferred candidate profile

  • Minimum 15 years experience in QMS injectables
  • Must have regulatory experience
  • Sound knowledge of Track wise and caliber QMS software
  • Sound knowledge of Change control, deviation , CAPA
  • Handling minimum 15 persons of QMS
  • Lead QMS for at least 5 years

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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