Job Description

Description:

The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements.


Schedule:


1st Shift 8:30am - 5:00pm Monday to Friday - Fully Onsite



Essential Functions:

  • Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor
  • Performs re-qualification of equipment, facility and utilities as required under supervision
  • Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
  • Draft Standard Operating Procedure(SOP) for new operational ...

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