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Test Cases Management System

Location:
Edison, New Jersey, United States
Posted:
March 01, 2018

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Resume:

Mohd Abdul Salaam

Email: ac4nvb@r.postjobfree.com

973-***-****

Professional Summary:

Over 7+ years of experience in software implementation, validation for the Life Sciences to

configure, support, validate, test the LabWare Global LIMS, SAP, Empower projects.

Expertise in developing the validation deliverables such as Risk assessment, Regulatory assessment,21 CFR part 11 assessments, GAP analysis document, Test Deviation Report, Validation plans, Validation reports, IQ/OQ/PQ protocols, Change controls and Problem reports.

Experience in Validation Procedures, technical writing for systems in compliance with cGMP, GAMP, cGLP, and cGCPs.

Experience with Laboratory Information Management System, Adverse Event Reporting System, Chromatogram System and Change Control Management System

Assisted in developing companies SOP’s, make necessary correction’s to the existing SOPs when required, policies and working instructions to comply with FDA regulations

Extensive experience in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specification Document (DS), Requirement Traceability Matrix (RTM), Process Maps, and Validation Summary Report (VSR).

Experience in writing Risk Analysis, Gap Analysis, and CAPA documents.

Extensive experience in writing and reviewing IQ/OQ/PQ protocols.

Experience in handling Analytical instruments like the HPLC, GC, GC-MS and LC-MS.

Good knowledge of HP Quality Center and QTP protocols.

Expertise in interacting with clients to gather the requirements, planning the system design, developing test strategy, creating test protocols and generating validation documents for various IT systems.

Experience in reviewing Corrective Action and Preventive Action (CAPA) and suggesting the remediation plan to mitigate the non-compliance.

Excellent interpersonal, verbal and written communication skills, decision-making skills, business understanding, and strong organizational skills

Ability to work in an action-oriented, fast-paced and rapidly changing environment and ability to lead virtual and global teams.

Professional Skils:

Computer system Validation

21 CFR Part 11 (210/211, 820),

GAMP, cGMP, GDP, GLP

Mapping of IQ to Design specifications

OQ to Functional requirement specifications

PQ to user requirement specifications

Risk Management Plans

SOPs

Applications/Environments

LabWare LIMS

( Laboratory Information management system)

Requirement Traceability matrix

ETL ( In flat files format)

CCMS (Compliance certification management system)

MES ( Manufacturing Execution System)

Sunshine act

SOX (Sarbanes-Oxley Act)

AERS ( Adverse events reporting system )

Use case-Activity Diagrams.

Data-Flow Diagrams

Testing Tools

HP Quality Center

Quick Test Professional

Operating System

MS Word, MS PowerPoint, MS Excel

Field Worked In Validation

Validation Analyst

Validation Tester

Technical Writing

WORK EXPERIENCES:

Role: Validation Consultant/Technical Writer

Otsuka, MD April 2016 to Present

Environment: HP-QC, SAP, LabWare LIMS V5.0.

Project Description: LabWare LIMS is the laboratory information management system used to handle a wide variety of laboratory analytical data from quality testing of raw materials, active pharmaceutical ingredients, finished pharmaceutical products and packaged finished products. It also handles data from supporting tests such as environment monitoring, stability, investigations and product complaints. The system is used to manage samples through laboratories, to store and retrieve test-related information and to control the release of products.

Responsibilities:

Customized, Validated and Documented different components of the LIMS modules in accordance to the business requirements.

Assisted in Authoring the Validation Master Plan for validating LIMS.

Responsible for analyzing and reviewing validation deliverables like User Requirement specification and Functional requirement Specification.

Developed, reviewed and assisted in the execution of IQ, OQ, PQ protocols, test cases, test scripts for automated and regression testing.

Executed the test cases stored in the Test Plan, imported locally to the Test Lab in HP Quality Center and reported the defects.

Authored Validation Summary Report to summarize and document all validation activities

Developed and reviewed Requirement Traceability Matrix and Work Instruction for various functionalities of the system.

Used Defect Management grid of Quality Center in logging and analyzing issues.

Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.

Performed user acceptance testing to the check the various functionalities of LIMS

Conducted GAP analysis and prepared Remediation Plan.

Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Computer system Validation Analyst

Integra Lifescinces, NJ Oct 2014 to April 2016

The scope of the project is to validate Adverse Event Reporting System (AERS) for Laboratory. The company provides highest quality pharmaceuticals and health care products to enhance human life. The adverse events caused during the clinical trials must be reported and should be in compliance with FDA regulations. Oracle AERS used as the solution.

Responsibilities:

Using backward/forward tracing of requirements and finding source using Requirement Traceability Matrix (RTM) for the application.

Wrote documents for reports that can be queried by type of adverse event, disease and principle investigator.

Wrote SOPs for training manual, storage and maintenance to comply with 21 CFR Part 11 and GLP requirements.

Developed Test plan and written several test scripts for validation testing.

Wrote GAP Analysis report and Remediation Plan document.

Reviewed and Documented IQ/OQ/PQ protocols.

Performed Load Testing, Black Box Testing, GUI Testing and Functionality Testing for the entire application.

Developed Test Cases and Test Scripts to perform regression testing using Win Runner.

Involved with the development team to verify bug fixing and update bug report status using Test Director.

Role: Technical Writer

Shantha Biotech (Hyderabad, India) May 2012 to Aug 2014

Environment: Adverse Event Reporting System, Empower, HP-Quality center

enter

Project Description :Shantha Biotech was one of the leading manufacturers in pharmaceutical’s .The job responsibilities at the client location involved writing, revising, reviewing and making changes to various Test plans, Test scripts, test cases and test procedures used in the manufacture of pharmaceutical’s. This also includes adverse events reporting, tracing the requirement matrix and validating the test cases using HP-Quality center.

Responsibilities:

Has assisted in authorizing the sources of Requirement Traceability Matrix Using backward/forward tracing for the application.

Submitted Final reports by Assisting documents that can be queried by type of adverse events, disease and principle investigator.

Reviewed, received and assisted SOPs for training manual, storage and maintenance to comply with 21 CFR Part 11 and GLP requirements.

Reviewed Test plan, Test Scripts and also assisted in writing several test scripts for validation testing.

Assisted in writing the GAP Analysis report and Remediation Plan documents when required.

Company: GBS Networks, Chennai, India Jan 2010 – May 2012

Test Engineer

Hospital Information System

Hospital Information System is the next generation Management system for today’s health care industry. It is highly automated system for Patient Registration, Maintain Patients Treatment History, Hospital Billing, Patient’s Record, Complete Diagnostic Reports, Inventory and Accounting with detailed reports generated about the patients, fees collection and accounts. The HIS System with its powerful features it is ready to meet requirements of all types of hospitals ranging from small to medium sized hospitals.

Worked as a Manual QA Tester.

Involved in testing on all stages of System Development Life Cycle

Performed integration testing and build verification testing.

Involved in generating Test plan and test specifications as per user’s business requirements

Regression testing was implemented at various phases of the test cycles.

Reported and tracked testing progress in the customized defect tracking system.

Worked with developers to fix the defects.

Education:

Masters in pharmacy(pharmaceutics), Jawaharlal Nehru Technological University, Hyderabad, India.

Bachelors in Pharmacy, Osmania University, Hyderabad, India.



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