Job Description
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 eventsSupport resolution of validation events and escalate concerns in a timely manner.Support in equipment and process walkdownsWeekly, Monthly and Quarterly reporting as required for own business areaSupport Monthly and Quarterly Quality Management Review (QMR) and...