A Validation Lead is hired to handle quality control and to validate various types of technologies and equipment. Typical work activities found on the Validation Lead Resume are – collaborating with engineers and other departments, reporting to senior management, monitoring all systems and units and ensuring its qualification to be validated, managing qualification program in accordance to necessary protocol, evaluating all data, ensuring implementation of all qualification, reviewing and approving preventive maintenance and critical systems, and training various departments.
Those seeking this job role should be able to demonstrate on the resume the following skills – technical skills, computer proficiency, multitasking skills, project management skills, networking skills, operational knowledge of data collection, exceptional knowledge of all rules and standards, skilled to interpret all validation requirements; and proficiency in understanding all guidelines for GMP facilities. Employers pick resumes that highlight a bachelor’s degree in biotechnology, or process controls.
Summary : Seeking a Validation Lead position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Skills : MS Office, Technical Writing.
Description :
Worked stream The purpose of this project is to revalidate all legacy Computer Systems/Applications to provide additional validation evidence to document the compliance of the system to J&J Quality standards.
Engaged in the validation effort for Systems/Applications such as Track-IT Help Desk system, eSAAF system, F-S463 FTest worksheet, F-S831Gage Ratio Worksheet and SCAR Elmira etc.
Involved in the legacy inventory review of GxP Desktop applications that satisfy a regulatory requirement (e.g. Excel Spreadsheets, Access Databases).
Responsible for authoring and revising the Compliance Analysis Reports to identify the computerized System/Application and the applicable compliance regulations.
Responsible for authoring the Compliance Plan to describe the approach that will be taken to ensure that the Systems/Application is developed according to quality software engineering principles.
Planned, and executed Validation of new IVD instruments and software.
Represented the Solutions Design & Validation team to the R&D Project Core Team and providing input and expertise on the needs of the end user.
Experience
10+ Years
Level
Senior
Education
BS
Validation Lead Resume
Summary : Over all 9 years of experience in Validation Lead as Validation Lead / Validation Analyst. Thorough Understanding of Software Development Life Cycle, firsthand experience in Estimation, Requirement Analysis, Test Planning, Test Design, Test Execution, Defect Management, Test Summary.
Focused on developing and delivering life-transforming therapies for patients with severe and life-threatening rare diseases.
Involved in multiple projects at Alexion Implementation and Validation of ValGenesis system, implementation of new process group enhancement and reconfiguration of TrackWise IT Change Control, involved in the Validation and Verification of Argus Japan, Network Infrastructure, Spotfire TrackWise upgrades, IRMS (Information Request Management System) systems.
Involved in implementation and validation of ValGenesis system in Alexion Pharmaceuticals by leveraging the vendor documentation.
Involved in generating the validation deliverables as per the Alexion standards using the Electronic Management system called firstdocs.
Involved in development of Validation Plan to validate the ValGenesis system.
Involved in assembling the Risk Analysis team and organize meeting to perform the requirement level of Risk Assessments, deriving the mitigation strategies and calculating the risk scores.
Participated in knowledge exchange with the R&D team (cross-functional and international) to improve and further develop our instrument and software solutions.
Experience
7-10 Years
Level
Management
Education
MS
Validation Lead Resume
Objective : Results-driven senior validation and FDA Compliance professional with over 13 years of Computer Systems Validation (CSV) and Business Systems Quality Analysis experience in the regulated life science industries. Strong knowledge of Software Development Life Cycle (SDLC) methodologies such as Waterfall, V-Model, Spiral, Iterative and Agile.
Skills : Managing Skills, Leadership.
Description :
Responsible for implementation of Labware LIMS (Laboratory Information management System) in GQAD department also responsible for equipment qualification.
Involved in the Computer System Validation & implementation activities.
Responsible for monitoring progress towards timelines, goals and objectives.
Responsible for preparing and updating of GQAD LACES Project Charter.
Recommended best practices, standards, technologies for implementing LIMS in GQAD.
Reviewed System Design and architecture documents.
Authored Master Validation Plan.
Experience
2-5 Years
Level
Junior
Education
Master's In Computer Applications
Validation Lead Resume
Objective : Seeking a challenging Validation Lead position in the Pharmaceutical/ Biotech/Healthcare industry where I can use my technical knowledge and skills to meet the organizational goals.
Skills : Computer Validation, MS Office.
Description :
Responsible for oversight and approval of direct reports documentation and testing activities of Quality Systems, in effort to meet the goals of client and IT management and staff.
Involved in multi in house developed applications to ensure that all the computer systems are validated and deliverables are documented.
Coordinated multiple project assignments with a team of technical communicators.
Reviewed, documented and approved by constant quality check with respect to proper guidelines of Lilly Quality Standards and Lilly Quality Protocols (LQP).
Associated with retrospective documentation and validation of few applications.
Hosted and supported customers and customer representatives during Validation execution
Tracked and reported all product features and workflow issues observed during daily usage.
Experience
2-5 Years
Level
Executive
Education
MS
Validation Lead Resume
Summary : Accomplished Validation Lead professional with 9+ years of progressive experience and proven record in Testing Process, project management, process improvement, business analysis/evaluation, product-development life cycle methodologies, and Defect Management processes and regulatory standards with good experience in the Life Science domain.
Skills : Selenium Web Driver, QTP, And UFT Framework.
Description :
Involved Testing Service Now application using QTP, QC/ALM.
Serviced Now tool is configured according to Amgen's requirements.
Prepared RTM, Test estimation, Automation Design Specification, test strategy and test plan, Validation Plan, Validation summary Report, Daily status Report, Weekly status report and Test Summary Report Guided the team in the test scenarios design, test scenarios development and execution Automation testing using QTP and UFT Framework.
Tested with RestClient and Back end testing with SQL TOAD.
Collaborated with field staff or customers to evaluate or diagnose problems and recommend possible solutions.
Installed and configured recreations of software production environments to allow testing of software performance.
Ensured all deliverables are in conformance with Healthineers policies, procedures, and objectives.
Experience
7-10 Years
Level
Management
Education
MS
Validation Lead Resume
Summary : Cumulative 8 years of Validation Lead Professional Experience as QA Analyst with extensive experience working in various domains built for Pharmaceutical, Insurance (PC, Auto, Life, and Health), Retail and Health Care with strong business and functional knowledge. Experience in Software Development Life Cycles (SDLC): Agile (Scrum), Iterative, GIP and Waterfall model.
Skills : Validation Testing, Planning Skills.
Description :
Assured standard operating procedures (SOPs) and other related documents are compliant with internal policies of organization and cGMP created Protocols for all the scheduled site visits.
Developed Testing Strategies and managed development of detailed Test plans and schedules, coordinated all the levels of tests for different test phases - planning, design, setup, execution, and defect management.
Validated the baseline EDC 2.0 system.
Assured that all validation documentation such as OQ's, PQ's, Process Validation and Software Validation are in compliance with cGMP's.
Coordinated Regression testing with external applications from outside the program and managed test environments for different technologies.
Assessed 21 CFR Part 11 requirements for Electronic Signature and Electronic Records to access data security issues like password protection and authorization.
Conducted data integrated testing by extensive use of SQL Involved in preparing Proof of Testing documents during test execution.
Experience
7-10 Years
Level
Executive
Education
Bachelors
Validation Lead Resume
Headline : Describing the experience and capabilities of a QA/Project Manager/Senior Validation Consultant. Previous positions include P/M for system development/coding; validation, remediation, and other computer systems-related testing programs. Strong project management of validation and consulting particular to Lab systems/cGLP and Pharmaceutical GxP environments.
Skills : Knowledge Of Network Security Concepts, Best Practices.
Description :
Designed test plans, scenarios, scripts, or procedures.
Tested system modifications to prepare for implementation.
Integrated test and user acceptance testing Develop testing programs that address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability.
Documented software defects, using a bug tracking system, and report defects to software developers.
Identified, analyzed, and documented problems with program function, output, online screen, or content.
Planned test schedules or strategies in accordance with project scope or delivery dates.
Coordinated user or third-party testing.
Experience
5-7 Years
Level
Executive
Education
MS
Validation Lead Resume
Objective : Hardworking, organized, Validation Lead professional with a proven background delivering sensible business technology solutions on time and under budget while working as a team member or team leader.
Skills : Team Work, Developing Skills.
Description :
Responsible for the review and approval of validation and qualification documents in support to the manufacturing systems (e.g. equipment, facilities, utilities, cleaning and process validations).
Ensured that all validations and qualifications were consistent with the client and client policies and procedures, and with regulatory agencies.
Reviewed and approval validation and/or qualification protocols.
Developed of validation strategies based on project objectives.
Developed and/or implemented of quality systems to monitor products and/or processes.
Evaluated of validation activities and documentation to ensure that they meet FDA standards and those of other regulatory agencies.
Participated in the change control systems of the facility.
Experience
2-5 Years
Level
Executive
Education
MS
Validation Lead Resume
Headline : Validation Lead with 5 years of experience in Assisting in campaign preparations. Assist with the generation of lifecycle documents including PIDs, impact assessments, criticality assessments, Quality Risk Assessments.
Skills : HPQC ALM, SOAP UI, Jira, SQL, SDLC.
Description :
Created Testing project, Test sets, and Test cases in HPQC ALM-11 using 21 CFR GxP guidelines.
Reviewed and approved test scripts with e-signature as a Test lead per GxP guidelines.
Created and approved defects in Quality center ALM.
Created Change Request-CR/Incident Report-IR in Validation environment using PTA/ADAM.
Created DIET cases (known software issues in Prod) using PTC Integrity 10.
Executed Performance testing with multiple users on various applications on different environments.
Created Testing progress report and Defect reports to discuss in daily/weekly meetings.
Experience
5-7 Years
Level
Executive
Education
M.S. In Computer Science
Validation Lead Resume
Headline : Reviewing Corporate Quality Guidelines and Corporate Quality Standard Operating Procedures identifying possible gaps, applicable industry practices not being implemented, and other Industry Standards.
Skills : Directing Skills, Developing Skills.
Description :
in charged of a team responsible for the development of the Operational Qualification Protocol for the USP Water Generation System and for the USP Water Storage and Distribution System recently bought and installed to increase production capacity from both Equipment and Computer Systems Validations perspectives.
Directly involved in the troubleshooting of the PLC's Ladder Logic Programming in order to correct problems in its sequence of operation and in the information provided in the screens of the system that varied from the Functional Specifications of the system.
Provided expertise in the actualization of Operational and Preventive Maintenance SOP's.
Reviewed System Development Life Cycle Documentation (SDLC) for Utilities such as DI Loops, PW Loops, Pre-treatment loops (RO Units, UV Lights, Carbon Filters, and Multimedia Filters), Compressed Air, Clean Steam, Plant Steam, Boilers and other equipment for compliance with Equipment Validation and Computer System Validation Standards and Policies as well as for 21 cfr part 11 compliance.
Reviewed System Development Life Cycle Documentation (SDLC), Change Control Documents, Deviations and Deviation Investigations for Biotechnology Equipment such as Holding Tanks, Crystallizers, Fermentors, Diaphragm Pumps, Centrifugal Pumps, Agitators and other pieces of equipment.
Developed documentation when necessary and Executed when necessary.
Performed Smoke, Functional, Negative, Integration, Adhoc, Stress, System and Regression testing on the application to verify the overall functionality of the system in Quality center.
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