Validation Lead Cover Letter

I submit this application to express my sincere interest in the validation lead position.

Previously, I was responsible for triage and initial debug of system-level issues seen during hardware and software development.

Please consider my experience and qualifications for this position:

• FDA regulations, 21 CFR Part 11, GxP requirement along with knowledge of GAMP, GDP, CSV (Computer System Validation) SOPs, SDLC and testing processes
• Planning and executing validation strategy, approach
• Familiar with FDA guidance, CFR 820.30(g) and IEC-62366 Human Factor
• Demonstrates potential for technical proficiency, scientific creativity, and collaboration with others and independent thought
• Presents results to program team (multi-disciplinary/cross-departmental)
• Frequently interacts with functional peer groups at various management levels
• Has broad understanding of regulatory requirements for computer systems and/or equipment typically in use in GxP environments
• Available to work on off-shifts and weekends as necessary

Please consider me for the validation lead opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for technical/product feedback to R&D and Marketing teams in order to assist with building the necessary software infrastructure and tools to facilitate product testing.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Validation/annual monitoring/revalidation activities scheduled in a timely manner that do not adversely impact production schedule nor audit readiness
• Training curriculum up-to-date
• Past experience in testbench architecture and hands-on development of components like BFMs, checkers, transactors, monitors and others using verification methodologies like System-Verilog VMM/OVM/UVM or equivalent is highly desirable
• High proficiency in independent debug of System Verilog RTL failures to root-cause functional bugs speedily
• Strong Computer Architecture and Digital Logic skills
• HBSS monitoring
• Metrics – capture and documentation
• Meet DoDD 8570.1/DoD 8570.01-M certification requirements for IAT III

I would like to submit my application for the validation lead opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for support and leadership to ensure compliance with both software and hardware validation regulatory requirements including 21 CFR parts 11, Annex 15 (Eudralex), GAMP and other guidance documents, as appropriate to the business needs.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience in manufacturing/ manufacturing science and technology/technical development/Quality
• Experience in executing process validation, having led and managed validation projects
• Good knowledge of MS Office and other Standard application
• Partner with, and provide regulatory guidance to, validation team members to assure efficient, timely completion
• Of all GXP CSV projects, resulting in GXP computerized systems that are compliant with regulatory and Shire
• Manage budgetary and cost issues within the quality function, particularly related to outside services budget
• Very strong relevant experience in executing, developing, and /or administrating GxP programs
• Previous experience in other Quality functions is an asset

I submit this application to express my sincere interest in the validation lead position.

In my previous role, I was responsible for software SDLC (Software Development Life Cycle) and validation expertise with regulatory compliance guidance and direction in order to meet with, and applicable regulations for computerized systems with the Flex Global IT as well as Flex Health Solutions organizations.

Please consider my experience and qualifications for this position:

• Experience auditing vendors and service providers
• Detailed knowledge in the application of CSV principles, GAMP cGMP, cGCP, 21CFR Part 11, and other regulatory requirements and industry best practices relating to GXP computerized system validation and system development life cycle activities
• Validation Master Plan (VMP) completed and up to date
• Product maintained in a constant state of validation
• No critical/major observations during audits/inspections, products maintained in constant state of validation
• Transfers/launches implemented on schedule and on target without validation related issues
• All related SOPs are updated on time
• Validation approach meets Novartis QM requirements, health authority and industry standards

Please consider me for the validation lead opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for review and input to the SQS validation team to ensure industry standard practices, such as GAMP 5, are employed when authoring validation documentation.

My experience is an excellent fit for the list of requirements in this job:

• Knowledge of Oracle AERS, SharePoint, BPM (Business Process Management)
• Able to work independently and supervise a team
• Knowledge of the GECARS Validation Process and / or the Cash Application process
• Creative approach to resolving technical issues, and balancing business needs
• Familiar with Development, QA and Production environment terminology and testing strategies
• Reviews/approves validation deviation investigation
• Develops validation plans for multiple site implementation
• Provides audit support for enterprise systems – customer/regulatory /corporate, as needed