MADJIDE GONDA

CLARKSBURG, MD

adc14a@r.postjobfree.com

713-***-****

WORK EXPERIENCE

JANUARY 2019 – PRESENT

COMPUTER SYSTEM VALIDATION ENGINEER, ACCENTURE

•Validating systems in compliance with the Quality Management System (QMS), System Development Life Cycle (SDLC), and all associated Standard Operating Procedures (SOPs).

•Support all validation activities for manufacturing service processes, medical device test fixtures, software's computer systems testing and documentation for IT quality systems applications.

•Performing risk assessment/gap analysis of the systems and Audit Trail review.

•Working with the lab teams to improve the data integrity process and ensure that the generated data is documented according to GxP and ALCOA.

•Author and perform, installation qualifications (IQ), operation qualifications (OQ)and the protocol qualifications (PQ) of Laboratory Analytical Instruments.

•Reviewing validation scripts for compliance with the internal Regulatory Compliance to meet 21 CFR Part 11FDA Regulations.

•Actively working with site Quality Assurance (QA)group with to ensure all Analytical Instrument Core Change Controls (CCC) /Deviations/Test Incident Reporting (TIR)/ Corrective Action Plan Assessment (CAPA) are properly assessed, documented and completed according to site procedures.

•Gathering User Requirements Specifications (USR) from the business team and analyze validation test data to determine whether systems or processes have met validation criteria or to identify the root causes of production problems.

•Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical and electronics.

• Train new validation analysts, setup and manage assignment profiles and direct assignments.

JANUARY 2017 – JANUARY 2019

VALIDATION CONSULTANT, ACCENTURE

• Designed, prepared, executed, and analyzed installation qualifications (IQ) of Laboratory Analytical Instruments by verifying software Installation, system configuration, equipment design features, safety features and environmental conditions.

• Performed operational qualifications (OQ), and performance qualifications (PQ) for over 50 complex analytical instrument systems, manufacturing equipment, laboratory utilities, and software programs used in the testing, processing, storing, and distribution of GMP products.

• Authored/reviewed Validation Summary Reports (VSR) to summarize all validation activities and route for approval electronically using a Documentum application (eDocs).

• Performed System Administration functions by setting up and maintaining User Accounts and Audit Trails and configuring system data storage and backup.

• Collaborated directly with contractors, suppliers and vendors to troubleshoot or install equipment with the lab or manufacturing plant.

JANUARY 2016 – DECEMBER 2017

QUALITY ASSURANCE TEST LEAD, ACCENTURE

•Led onshore and offshore testing team activities involving Oracle and Pegasystems.

•Coordinated the design and implementation of tests, for debugging, and taking actions to avoid a deployment delay in order to deliver a high-quality product, beyond the expected standards.

• Monitored the quality assurance metrics and ensure all the defects have been discussed and resolved and send a daily report to the Project Manager.

•Led and reviewed the creation and execution of detailed, comprehensive and test plans and test cases for development tasks as well as for visual design testing.

•Actively Worked with client to establish and maintain a consistent test methodology and to resolve questions during the testing process.

•Managed the day-to-day activity of resource, resources expenses approvals and forecasting.

JANUARY 2015 – DECEMBER 2015

Chemical Engineer- Data Analyst, ACCENTURE

• Selected the best approach for the successful outcome of the project based on the experience and the expert's advice.

• Planned, scheduled and carried on the necessary tests to obtain a result reproducible coming up to quality expectations. This include pilot batching and scaling qualities.

• Analyzed experimental results and working together with the experts (R&D) to redirect the project, if necessary.

EDUCATION

BACHELOR OF SCIENCE, PRAIRIE VIEW A&M UNIVERSITY

Major: Chemical Engineering

Minor: Petroleum Engineer

SKILLS

Aspen Plus

Delta-V

Eclipse

LabWare -Laboratory Information Management System.

KNEAT SOFTWARE

Empower 3 Software

Analytical Testing in pharmaceutical and biopharmaceutical industry.

Reservoir Engineering

Project Management

Data Analysis

Data Integrity

21 CFR Part 11 FDA Regulations

Knowledge of FDA regulations, application of cGMP and CGDP

Agile and Waterfall Methodologies

Process Engineering Design and Support

Chemical Engineering Process Design

Process Safety

Risk Assesment

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