Quality Engineer
3 days ago
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.
- Work in-accordance with HSE manual and documented procedures, and reporting HSE issues to the respective areas.
- 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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