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.
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.