**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 escalate 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 Review (QMR) and Business Management Re...