Fatima Osmani

Verification, Validation and End to End Testing of Software, Applications and Systems.

Temperature

Mapping, Project Engineering and Project Management. Generating/executing protocols (IQ/OQ/PQ), generating requirement specifications (FS/FRS/URS), and generating/revising SOPs. cGMP, GxP and GDP techniques and experience/knowledge with 21 CFR Part 11 and FDA regulations. Performs good with numbers and statistical analysis. Can interpret and collect statistical data based on the given data. Works well independently and in a team environment.

Validation Engineer - Amgen - Thousand Oaks

(2024-02)

• Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
• Creating new test methods and the required test fixtures.
• Creating all the required documents for qualification, validation and transfer of test methods.
• Create, revise parts and drawings using CAD software (SolidWorks Preferred).
• Perform data analysis using Minitab and interpret data.
• Performing and operating the tests required for qualification, validation and transfer of the methods.
• Creating training documents.
• Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.

Computer Systems Validation Engineer - PSC Biotech Corp

(2022-03 - 2023-11)

• Perform execution of CSV protocols
• Reports on automated tests and defects
• Changes made to existing processes
• Knowledge of SDLC (Software Development Life Cycle)
• Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT, test cases)
• Participate/support the planning, development, and implementation of computer systems validation documentation.
• Author, Review and or approve scheduled periodic reviews.
• Participate in computer validation project activities and create computer system planning documents and testing protocols.
• Understanding of workflows and regulatory requirements
• Provide range of support in a variety of CSV tasks
• Review and modify Standard Operating Procedures (SOPs)
• Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements.
• Develop and implement procedures for emergency shutdowns.
• Mentored engineers on the team with developing documentation and managing a project.
• Project Coordinator duties, responsible for all documents before go live date.

Validation Engineer - Ellab Corporation

(2020-11 - 2022-03)

• Assist in managing delivery of validation projects
• Author, review, approve and execute validation documentation including protocols, summary reports, procedures, other lifecycle documents.
• Performing calibrations and verifications in support of validation and engineering projects.
• Interfacing with customers to develop validation documentation, schedule projects, and communicate study results.
• Training new users and providing technical support.
• Oversee plant performance and oversee for improvement.
• Recording and reconciling project costs and information required for final billing.
• Analyze and interpret data from qualification studies if it meets acceptance criteria.
• Troubleshooting and debugging customer and Ellab equipment.
• Support and maintain the validation department equipment inventory.

Associate Engineer - Derm Cosmetiques - Agoura Hills

(2020-06 - 2020-11)

• Perform technical support when necessary.
• Understands test methods of physical characteristics and interprets relevant test data to improve the overall design.
• Monitor various projects and ensure effective performance of engineering processes and perform tests on the same.
• Attend meetings and interact with managers about consumer and other technical aspects such as NDA.
• Assists in the development of management information systems to aid in the control and development of company goals.
• Performing IQ,OQ, and PQ validations.
• Debug and troubleshoot issues with QA web applications.

Chemist - Puretek Corporation - Panorama City

(2019-06 - 2020-06)

Worked in a quality control lab for the first four months before transferring to R&D Lab.

• QC Lab executed several physical tests using equipment such as an IR scan, UV scan, viscometer, densitometer, and familiarity with HPLC and UPLC.
• Performed routine maintenance on equipment and determined when and what kind of maintenance is needed.
• Monitored batches in production
• In the R & D Lab I am creating batches and editing formulas to make shampoos, toners, body wash, lotions, daily microfoliant, lozenge, probiotics, vitamins, melatonin liquid, and energy shots.
• Entered data, verification, analysis, and technical reports for process monitoring.
• Highly proficient in good manufacturing practice (GMP).
• Performed, released, and stability testing in a GMP laboratory.
• Manage the equipment calibration program and Fill Line equipment
• Collect and document study details and results in lab notebook
• Review formulas while making large batches with the compounders.
• Work with the (R&D) team to transition small batches from the lab to full-scale production.
• Keeping backroom inventory neat and organized to ensure safety.

Lab Technician - Derm Cosmetiques - Agoura Hills

(2017-06 - 2019-05)

• Conduct chemical experiments under the guidance of the Head Chemist.
• Document test procedures and results and report the same to the Head Chemist for analysis.
• Coordinate, plan, and perform daily laboratory functions.
• Sole developer of the company's website.
• Served as a friendly, hardworking, and punctual employee
• Organized and prioritized work to complete assignments in a timely, efficient manner.

Bachelors - Chemical Engineering - California Polytechnic State University, Pomona (2016-09 - 2019-05)

Associates - Mathematics - Los Angeles Pierce College (2014-04 - 2016-04)