Javier Alva personal email
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Over 30 years of experience in IT as Senior Project Manager, Senior Business Analyst and Senior Validation Lead with system implementation for Engineering, Manufacturing, Pharmaceutical, Accounting, System Validation, Supply Chain, ERP, and related areas. A Project Manager and Business Analyst, with expertise in IT system implementation initiatives, ensuring delivery of projects within the time and cost parameters. Led projects for development and implementation of software applications. A Validation Lead Trained on Information Security Standards, Software Validation and FDA 21 CFR part 11, SOX Compliance and SLDC.Proven ability to successfully lead cross-functional teams, develop strategies to address complex business problems through the introduction of cost effective IT solutions as well as managing their development, validation and global implementation. Adept in analyzing information system needs, evaluating end-user requirements, custom designing complex information systems management and assisting in technology adoption across the organizationSpecialties: • Managed multi-year, multi-million dollar, highly regulated (FDA CFR 21 Part 11 validations) global projects• Managed onshore and offshore teams• Expertise in merging and divestiture Pharmaceutical IT systems • Aligning technology resources with business goals and enable optimized business processes by employing cost effective information technology solutions
Bms - Consultant (Sikich)
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Senior Validation LeadBms - Consultant (Sikich) May 2022 - PresentNew Brunswick, NjBMS Consultant Validation support for MES Emerson Global system.Validation support for review pre and post scripts (and approvals) using HPALM.Support the following documents: User Requirements, Design and Configuration Specs, Traceability Matrix for core and extended requirements.
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Project Validation LeadSikich Jun 2021 - Apr 2022Princeton, NjValidation Lead implementation for Trackwise and Trackwise Digital.Updating / Creating validation documents: Validation Plan, User Requirements, Functional Specs, IQ, OQ, PQ, UAT, Traceability Matrix and Validation Summary Report.Supporting Archiving and Migration for Trackwise Digital.Complete validation for the following clients: Aurobindo, NRCC (National Research Council Canada), Honeywell, Abbott, Alkermes, Bright Path and ByHeart. -
Senior Validation LeadBms Celgene - Consultant (Process Stream) Jun 2020 - May 2021Summit, NjuSupporting the validation at Celgene (BMS division).Validation support for Pre-License / Approval Inspection (PLI) remediation for stand-alone computerized systems used in the CAT-T Technology Process.Updating / Creating all validation documents and execution of the protocols. Complete validation of the following stand-alone systems: MACSQuant, Biosystems 7500 Fast Real-Time, Biomerieux BacT and Ellab.
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Senior Validation LeadRegeneron - Consultant (Savvy Computer Solutions) Nov 2017 - May 2020Albany, NySupport the entire validation process for Regeneron Inc.The entire validation process includes the following documents: Validation Plan, User Requirements, Functional Requirements, System Designs, IQ, OQ and PQ, Traceability Matrix, Validation Summary Report.Generates, executes and review validation protocols and associate data for conformance to regulation, SOPs specifications and other acceptance criteria.Generate and review Deviation Notifications, Deviation Investigations, Change Control, Risk Assessments, CAPA and Audit Trail documents.Perform the Data Integrity Assessment.Complete validation of the following systems: Johnson Controls, MES (Werum integration), Adobe Acrobats approvals, Oracle Serialization (Tracelink) and Controlant Cold Chain.
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Senior Validation LeadAvara Pharmaceutical - Consultant (Usdm) May 2017 - Oct 2017Princeton, NjSupporting the SAP Validation at Avara Pharmaceutical (Norman, OH). The validation process was performed using the HPALM (HP Application Management System).Support the Validation documents for OQ (Operating Qualification) and PQ (Performance Qualification) in HPALM.Support the validation process for LIMS and the interface with SAP.
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It DirectorAcebios Feb 2013 - Apr 2017Princeton, NjSupport the QMS (Quality Management System, eBPR for CMO (Contract Manufacturing Organization) plants in China.Support the validation software to meet the FDA requirements.
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It Consulting/Project ManagerRobert Half Management Resources Feb 2011 - Feb 2013
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It Senior ManagerPfizer Jan 2001 - Nov 2009Lead the Customer Service PGM IT / MRP system for USA, Latin America, Asia and Africa regions. -
It Project LeaderPfizer Jan 1992 - Dec 2000Lead the design and development of the MRP system for the following modules: Planning, Cost Accounting, Plant Budget and Interfaces with the Financial systems (Sun, Computron and Oracle) -
It Project AnalystPfizer Feb 1989 - Dec 1992Support the development of MRP AS400 system for the following modules: Resource Master, Work in Process, Inventory Control, Procurement and Interfaces with other corporate systems
Javier Alva Skills
Javier Alva Education Details
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Administration -
Economics
Frequently Asked Questions about Javier Alva
What company does Javier Alva work for?
Javier Alva works for Bms - Consultant (Sikich)
What is Javier Alva's role at the current company?
Javier Alva's current role is Senior Validation Lead IT at Sikich.
What is Javier Alva's email address?
Javier Alva's email address is ja****@****hoo.com
What schools did Javier Alva attend?
Javier Alva attended Centenary University, Universidad De San Martín De Porres.
What skills is Javier Alva known for?
Javier Alva has skills like Erp, Business Analysis, Manufacturing, Budgets, Process Improvement, Change Management, Cross Functional Team Leadership, Program Management, Sdlc, It Management, Business Process, Requirements Analysis.
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javier alva
Ben Lomond, Ca
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