Sr CAPA Engineer

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ADDENDUM:

GMS CAPA Office Focus



* Responsible for development of an appropriate strategy to implement all necessary requirements from FME Quality Management and formerly used NC/CAPA tools into one global electronic NC/CAPA tool.


* Assists global NC/CAPA process owner with process definition, documentation, implementation, and maintenance.


* Monitors process as well as tool performance to eliminate deviation and improve efficiency.


* Ensures the GMS NC/CAPA process fulfills applicable regulatory and business requirements.


* Assist process owner to develop strategy to implement a harmonized FME NC/CAPA process and tool integration of all requirements from CQMS, IMS, and NA quality management systems


* Conduct process design & development, document creation, review and assessment, change initiation, user training, and global implementation in accordance with an established project plan


* Generate training materials and provide training to SMEs or key users in all applicable user groups


* Support global rollout of any new or revised NC/CAPA solutions (process enhancement, tools, techniques, etc.)


* Design overviews and dashboards based on defined KPIs and monitor metrics to ensure full transparency of ongoing NC/CAPA activities


* Generate QDATA reports and assess performance trending


* Make a judgment based on the trend and take timely actions to ensure the compliance of the process and the correctness of the user's use


* Ensure existing deviations and penitential nonconformities related to process and electronic tool are recognized and eliminated in a timely manner


* Develop strategy to improve process and tool effectiveness while controlling new risks brought to the process or business

EXPERIENCE AND REQUIRED SKILLS:         


* Experience participating in health authority and/or Notified Body inspections is preferred


* Availability to work different time zones as per business need.

PURPOSE AND SCOPE:

The Senior Engineer, CAPA is responsible for coaching CAPA Engineers to ensure CAPAs (corrective and preventive action) and Non-Conformance (NC) investigations are executed in compliance with company procedures and FDA Regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  


* Utilizes Quality System to ensure CAPA system is successful and compliant.

Partners with Quality Systems personnel and responsible for driving continuous improvement on effective CAPAs as a core Quality Business process/function(s).


* Responsible for assigned CAPAs and will act as CAPA lead to CAPA Owner/Team providing project direction throughout CAPA stages.

Performs Quality Approver functions for CAPA and NCs to ensure compliance to applicable procedures.


* Applies sound, systematic problem-solving methodologies i...