MAIN PURPOSE OF ROLE Ensure that change control and validation activities are executed in a timely manner.
Main Responsibilities - Comply to all policies and standards.
- Develop, execute and review validation protocols and related documentation in accordance with Abbott procedures and policies.
- Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes.
- Manages site Validation Review processes (VRB), review and approve site change controls (plant and laboratories related) and validation change requests.
- Perform root cause analysis and identify corrective and preventive actions in addressing quality events
- Support resolution of validation events and elevate concerns in a timely manner.
- Support in equipment and process walkdowns
- Weekly, Monthly and Quarterly reporting as required for own business area
- Support Monthly and Quarterly Quality Management Revi...