Senior Quality Engineer

Responsible to assist and support Failure Investigation, root cause analysis, generation and execution of corrective and preventive actions.

Responsible to manage and support validation/qualification activities for new product/process/raw material/computer systems qualification.

Support and coordinate re-evaluation activities for existing/legacy systems.

Responsible to ensure compliance and provide guidance plus technical support to QA/DHR/Manufacturing.

Responsible to perform product/process and system risk assessment.

Responsible to lead and drive Quality and compliance Improvement Program and support Continuous Improvement Plan (CIP) using LEAN and SIX SIGMA principles.

Lead/support Failure Investigation and root cause analysis, generation and execution of corrective and preventive actions.

Manage GxP and validation/qualification activities.

Ensure GMP compliance and provide technical support to DHR/QA/Production.

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