Resume

Gayathri Mahagamarachchi

acw079@r.postjobfree.com 817-***-**** Berkeley, CA, 94709

Highly disciplined, technically advanced, worldly engineering graduate with two years of excellent performance on the quality control validation side of the pharmaceutical sector. Proven ability to achieve and exceed goals in high-pressure environment, offering an array of transferable skills and engaged in professional development courses to expanding knowledge within the business arena and successful completion of Credential of Readiness at Harvard Business School. Areas of Expertise include:

Strategic Planning

Communication Skills

Attention to Detail

Business Analytics

Team Player

Matlab

Microsoft Office Applications

Computer-Aided Design

Customer Service

Experience & Notable Contributions

Bayer Pharmaceuticals, Berkeley, CA

April 2014 – June 2016

Instrument Qualification and Software validation Specialist

Perform analytical computerized instrument and software validation, validation periodic review, and risk assessments to support variety of the labs within Quality Control organization.

Reviewed Computerized Instrument System Validation Protocols in conformance with 21 CFR, Part- 11, Traceability Matrix and User Requirements.

Successfully qualified, validated, and deployed Waters Empower 2 Chromatography System.

Reviewed validation protocols and reports for equipment and instruments associated with manufacturing and laboratory areas, including evaluation of proposed test plans and acceptance criteria, auditing of raw data and evaluation of deviations and conclusions derived from validation studies.

Supported the creation of, User Acceptance Testing, and validation of QC's Laboratory Information Management System.

Revised instrument hardware and software operation and maintenance SOPs for QC equipment.

Supported QC Laboratory Information Management System (LIMS).

Worked closely with engineers and contractors to resolve any discrepancies encountered during validation studies and calibrations.

Write, execute and summarize functional specifications, installation, operation, performance, and system operation qualifications, engineering change order and validation protocols for QC, analytical and in-process systems.

Analyzed system requirements and developed Test Plans, involved in developing Test Scripts for manual testing.

Drafted and revised Standard Operating Procedures (SOPs).

Reviewed and approved all PMO(s) and Work Orders for laboratory equipment, as well as calibration records of laboratory equipment to ensure the calibration parameters met requirements.

Evaluate, review, and approve of validations documentation associated to Manufacturing, Process, and Engineering related Computer / Computerized Systems, Analytical Laboratories Systems, viewed from the Quality and Compliance perspective, which includes document correctness, adequacy, and compliance with the regulatory aspects, cGxP, FDA 21 CFR Part 11 rules, and ISO requirements.

Involve in the Validation and PQ execution to provide the correct process and documentation in order to meet with the Computerized System Validation requirement.

Validated and used Empower Chromatography Data Software by Waters

Provided analytical support for generic drugs formulation and stability groups, utilizing various types of analytical techniques including instrumental chemical and physical testing methods (GC, HPLC, KF, etc.).

Prepare protocols and assemble final packages with high quality and accuracy.

Interact with Regulatory agencies, customer, and internal auditors/inspectors as needed. Support regulatory filings with documentation as needed.

Abbott Laboratories, Irving, TX

Feb 2010 – June 2013

Validation Engineer

Worked as a Validation Engineer for the Abbott’s manufacturing facilities for the Endovascular Solutions group at Abbott Vascular.

Validated computerized laboratory equipments and transitioned into computerized systems validation and performed 21 CFR Part 11/820 gap analyses on existing and new computerized systems

Supported the creation of, User Acceptance Testing, and validation of QC's Laboratory Information Management System.

Created and revised instrument hardware and software operation and maintenance SOPs for QC equipment.

Supported QC Laboratory Information Management System (LIMS).

Wrote, executed and summarized functional specifications, installation, operation, performance, and system operation qualifications, engineering change order and validation protocols for QC, analytical and in-process systems.

Analyzed system requirements and developed Test Plans, involved in developing Test Scripts for manual testing.

Drafted and revised Standard Operating Procedures (SOPs).

Conducted GAP analysis and prepared Remediation Plans in compliance with FDA regulations.

Validated computer system interface with laboratory equipments such as Spectrophotometer, GC, HPLC.

Equipment Qualification (Blender, Oven, Autoclave, TOC Analyzer, Balances)

UNIVERSITY of TEXAS Arlington, TX 2013-2014

The research laboratories of this large State University

Research Assistant at Integrated Micro/Nanofluidic and Autonomous Vehicle Laboratories

Took part in leading-edge research on micro-controller boards effectively to develop a setup to different membrane

and electroplating experiments to minimize human involvement; as well as control systems for airships.

Key Accomplishments:

Made optimal use of PowerPoint and AutoCAD to prepare and deliver biweekly briefings.

Advanced the research that improved the operations of the University of Texas’s airship, which is both a technological platform and an iconic crowd pleaser at sporting events.

Education & Training

Bachelor of Science in Mechanical Engineering

UNIVERSITY OF TEXAS Arlington 2013

Credential of Readiness (CORe), Harvard Business School, 2016

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