Alfredo Estrada Email and Phone Number

R&D Project Management

-Design Validation-Design Verification-Transfers to Mfg-TM Validation for DV&V

-Overall support for Mfg.-Automation Solutions.-FAT, SAT studies-CapEx projects-Design Transfer to Mfg. -Validations (Validation Plan, IQ/OQ/PQ/PPQ)

+Core activities: Generate and execute Validation Protocols and Reports for: Facilities, Utilities, Equipment, Processes and Physical Test MethodsEnsure and preserve the evidence that all elements included in a validation are evaluated and comply with the procedures and requirements of the company and FDA requirements for medical devices.Author and execute Validation Plans, Validation Change Assessments and Engineering Studies.+SME activities: Review, approve and provide support on the development of validation documents: -Validation protocols and reports -Validation Plans-Engineering Studies-Validation Change Assessments-Validation Review ReportsProvide guiadance and expertise to other departments and sites on their validation activities.

Support to Development and Implementation of New Products.Audit and changes to the bills of materials (BOM).Execute Test Methods for root cause analysis.

Calibration Schedule and activities in DirecTV and Nokia BU's.Assign Asset number for new equipment and startup calibration. Overall support to other BU's and facilities.