Yasar Mohammed

(305) 432-5454
[email protected]

Test Method Validation Engineer

 6 Years of experience as a Validation professional in the Medical industry, known for the ability to develop and
implement processes that positively impact the compliance results.
 Hands-on Computer System Validation, Manufacturing Equipment Installation and Qualification, Test Method
Validation (TMV), and R&D experiences.
 Strong understanding of 21 CFR Part 11 drug GXP requirements including electronic records, electronic
signatures, system validation strategies and documentation.
 Working experience in FDA regulated environment and research laboratories with good understanding of cGxP
(cGMP, cGDP, cGLP) standards and Risk based validation.
 Experience in generation of status reports and metrics using the integrated TrackWise system along with
crystal reports and their development.
 Expertise in product failure analysis, DHF/FMEA assessment, Risk Management (ISO 14971), process
improvement. 
 Configured changes including updates to global change control process.
 Competent in quality system and standard 21 CFR (part 11, 50, 58, 210, 211) and GAP Analysis.
 Good knowledge of Software Development Life Cycle (SDLC), familiar with Software Methodologies like
Waterfall, Spiral, V-Model and Agile in relation to development and testing.
 Experience in reviewing and developing User Requirement Specifications (URS), Functional Requirement
Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and
regulation.
 Expertise in developing the validation protocols, executing tests, and construction of summary reports for IQs,
OQs and PQs.
 Experienced in drafting new SOPs & training users on SOPs for various systems.
 Expertise in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated
environment.
 Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the
remediation plans to mitigate the non compliance.
 Developed comprehensive Test Plans, Test scripts, Test Case and Test Reports. Performed Regression, Black
box, System and UAT testing using both HP Quality Center and paper based manual testing.
 Proficient in dealing with Change control management systems, Laboratory information management system
(LIMS), Adverse event reporting system (Argus safety AERS), Enterprise document management system
(EDMS).
 Hands on experience in tools like HP Quality Center, TRIM Context Dataset, and Documentum.

Work Experience:

Zimmer, Warsaw, IN
Feb’2017 – Till Date
Test Method Validation Engineer

Responsibilities: 

 Performed Test Method Validation on Disposable medical devices by Executing Variable and Attribute test
methods and analyzed the results using MINITAB.
 Writing mechanical test protocols for R&D testing.
 Involved in the creation of DHF Index & DMR Index.
 Performing test method validations as per FDA regulations and ensure product compliance.
 Prepared equivalency reports for existing validated methods with non-remediated methods and hence saved
time and resources without test method executions thus helping Baxter Healthcare close the FDA remediation
sooner than anticipated.
 Conducted global supplier assessments to meet ISO 9001, ISO 13485, ISO 14971 and FDA 21CFR820
requirements and regulations. 
 Ensure products comply with FDA and ISO 13485 quality standards.
 Co-ordinated with Manufacturing TMV to perform remediation for Final release test methods, Receiving and
Inspection test methods and IPSO (Inter Plant Shipping orders) test methods.
 Prepared final reports for the tests performed and drafted Final Summary Report for FDA Audit purposes.
 Drafted and executed IQ, OQ, PQ and PV validation protocols for equipment and instrument assembly
processes.
 Successfully completed new product qualification, managed time lines for product qualification, product
testing, analysis of test results (using MINITAB) and submission of reports.
 Laboratory analytical Instrument qualifications, including IQ/OQ/PQ. Writing, reviewing, approving, execution
of the qualification protocol, calibration/Preventative maintenance SOP's, Gap Analysis, and summary reports.
 Involve in Change requests and Change control activities.
 Assist in CAPA's by extracting Complaints data from Smart Solve Complaint Management System (TrackWise).
 Create System Requirement Documents and Traceability Matrices.
 Ability to use TeamCenter and other Product Lifecycle Management databases.

AngioDynamics, Inc., Latham,NY

Responsibilities: 

 Involved in development and execute Test Method Validations (TMVs), develop, execute, review and approve
Validation protocols (IQ, OQ, and PQ) and reports
 Drafted IQs and PQs for all equipment involved in the move as well as OQs for equipment not previously
validated.
 Familiarity with ISO 9000, ISO 13485 standards and FDA Current Good Manufacturing Practices.
 Performed a gap analysis on previously performed OQ activities
 Assist with the creation and revision of current manufacturing instructions and drawings
 Train personnel on manufacturing instructions, standard operating procedures and good manufacturing
practices for the stent graft and delivery system.
 Provide technical input for specific functions within Manufacturing departments
 Assisted in the development of Test Method Validation protocols specifically for medical devices, review input
and output design requirements, verification and validation, hazard analysis and traceability per risk
management (ISO 14971), FDA QSR, ISO 13485.  
 Performed first article inspection of parts from new facility and compiled reports
 Drafted PFMEAs for three product lines produced at new facility
 Assisted in making Control Plans for two product groups of blood glucose sensors
 Took charge of Production Part Approval Process (PPAP) as a liaison between SQE and Process Engineers
 Wrote TMVs for both attribute as well as variable test methods
 Performed root cause analysis on various failures in production line at new facility
 Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation
 Remediated the TMV's for identified gaps
 Responsible for assisting in creation and approvals of Validation Master Plan (VMP)
 Updated standard TMV procedures to bring up to current quality system regulations
 Developed TMV protocols and reports and conducted necessary testing
 Experienced in statistical data analysis using Minitab (Gage R&R, Anova studies) and Distribution Analyzer.

CSI Medical, Gallatin, TN

 Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test
Method, Variable Non-Destructive Test Method, Analytical Test Method and Inspection Test Methods,
Mechanical and Dimensional Test Methods)
 Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation
 Remediated the TMV's for identified gaps
 Updated standard TMV procedures to bring up to current quality system regulations
 Developed TMV protocols and reports and conducted necessary testing
 Experienced in statistical data analysis using Minitab (Gage R&R, Anova studies) and Distribution Analyzer
 Authored Test Method Validation protocols/reports for validating the existing tests within the process, leading
to development of Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocol/reports for
the manufacturing machine/equipment
 Experienced in validation concepts, procedures, protocols and requirements
 Experienced in IQ/OQ/PQ/TMV/Software Validation in manufacturing
 Experience in Gage Repeatability and Reproducibility, Statistical Process Control,
 Working knowledge in ISO 13485 Medical devices - Quality management systems
 Proficient in Risk Management, DFMEA, PFMEA, and CAPA
 Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements
and quality objectives
 Responsible for Creation, evaluation, and validation of product and process test methods
 Authored test methods for some existing work instructions and developed strategies to validate them
 Experienced in Validation and Verification Activities for Medical devices
 Works with Quality to address Product Quality, determine Root Cause and fulfill the requirements of the TMV
CAPA
 Prepared and executed IQ, OQ, and PQ qualifications for production equipment and process methods
 Participated on cross-functional teams for the remediation process and rewriting of the validation procedures
 Experience includes IQ/OQ technical writing and execution, commissioning, change control administration and
SOP adherence
 Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in
compliance with 21 CFR Part 11 Regulation and participated in preparing the implementation plan
 Prioritize, analyze and resolve technical issues during IQ/OQ/PQ execution and develop effective solutions
 Assessed change controls, facility work orders and equipment risk assessments to ensure compliant/validated
state of all GMP equipment and systems

Shire Pharmaceuticals, Cambridge, MA

Responsibilities: 

 Established Equipment Management Program for suitability, preventive maintenance, and calibration of
production equipment.
 Wrote Process Validation Procedure to provide Characterization, IQ, OQ, and PQ requirements
 Wrote procedures for sample size and statistical techniques for validation and process activities
 Wrote test Method Validation procedure including guidance documents for attribute, variable, and destructive
gage R&R
 Developed injection molding supplier component validations utilizing the Scientific Method techniques.
 Activities included Equipment Requirement Specification (ERS), Equipment Qualification (EQ),
 Test Method Validation (TMV), Manufacturing Work Instruction (MWI), PFMEA, Software
 Validation, Process Validation (IQ, OQ, PQ), Verification, and Change Control
 Operations included UV bonding, gluing, pad printing, hot stamping, tube cutting, suture ring assembly, tip
forming, punching, and sterile packaging
 Maintained production support including Non-Conformance Report (NCR) and Corrective and Preventive
Actions (CAPA)
 Assigned Equipment Manager role to manage suitability, calibration, and preventive maintenance of all
production and development equipment.
 Writing, reviewing, and approving SOP (Standard Operating Procedure), Protocols, Final Reports, Master
Validation Plan, and Production plan for quality assurance/ product support
 Performed Design of Experiments (DoE) using Minitab 16 and analyzed various process parameters with the
use of statistical tools (SPC) such as Gage R & R, Gage linearity and Bias study
 Assisting in preparation of IQ, OQ, and PQ protocols and writing summary reports
 Creating Master Validation Plan flow chart to synthesize activities and shorten project completion time
 Knowledgeable in FDA regulations, ISO standards, and ASTM standards

Education: Bachelors in Mechanical Engineering.