Chantal Ogando Bautista

- Lead cross functional teams to evaluate, develop and manage projects for new product, processes and ongoing lifecycle management.

- Monitor and track project progress based on management expectations.

- Manage communication mechanisms to obtain the stakeholders engagement and the management and suppliers as well.

- Define and execute qualification/validation strategies.

Quality engineering representative of a Transfer Project including activities as:

- AQP creation and update as required within the specifications.

- Revision and approval of validation protocols IQ/SQ/OQ/PQ.

- Design and execute Test Method Validation.

- Creation and Verification of Change Control activities and Master Validation Plan of the process.

- Design Validation strategies based on Risk Management guidelines.

Coordinate the following areas/system:

- Nonconformance

- CA/PA

- Supplier Corrective Action

- Material Review Board

Also, support the audit strategy of the management and compliance system.

Management and lead the following areas:

- Nonconformance product area

- Calibration

- Documentation system

- Complaints and CA/PA

- Audits. Internal, external and third part

- Risk Management

- Plan, execute and implement local and divisional projects of new and ongoing processes and products.

- Manage Risk Management System.

- Manage statistical data to create new tools in the process.

- Identify failure modes and controls on manufacturing processes to update pFMEA and Control Plans for manufacturing processes.