Chathura Munidasa

** ***** ****** - ******* ******* L4J 6G3

905-***-**** (Home) 416-***-**** (Mobile) acxqiq@r.postjobfree.com

Highlight of Skills

Relevant skills and experience

. Experienced in working in an FDA audit environment.

. Knowledgeable in GxP (GMP, GDP, etc.).

. Knowledgeable in generating and implementing CAPA to address

Deviation/Non-conformance and Change Control Processes (i.e. Document

Change Notice, Engineering Change Notice, etc.).

. Designed a Gas Compression Unit optimized to minimize project costs

while maintaining uptime.

. Created a performance test module for a particular medical device

following RESNA standards.

. Asset Registration Form Preparation and CAPEX Spend Tracking.

. Created Construction estimates based on tenders from past projects.

. Created Gantt Charts in MS Project for CAPEX projects.

. Managed Document Control System as per Quality Procedures.

. Coordinated and conduct Internal Audits.

. Coordinated Non-Conformance Process.

Computer skills: Aspen Plus, SAP, NAV, AutoCAD, SolidWorks, BarTender

Automation, Microsoft (MS) Word, Excel, Power Point, Visio, Project,

Access.

Laboratory skills: Experienced in Chemical Laboratory Techniques. Trained

in WHMIS.

Experience

Quality Coordinator at Motion Concepts Ltd.

2015 - Present

. Analyzed Purchase Order forms to generate assembly-drawing lists used

by production.

. Provided formal training to new employees on Good Documentation

Practices (GDP).

. Participated in company's first FDA audit under Medical Device

Regulations Act 21 CFR Part 820 by managing the backroom effectively;

ensuring the correct documentation was prepared for each request in a

timely manner. Audit findings for QMS (Quality Management System) were

minor, and remediated successfully

. Coordinated the Document Change Notice process, Engineering Change

process, Research and Development process, and Deviation process.

. Maintained Master Documents released through Document Control System.

. Coordinated and conducted internal audits. Ensured audits conducted as

per published internal audit schedule. Generated CAPA to address non-

conformance.

Engineering Co-op at Sanofi Pasteur

2013 - 2014

Project Management:

. Prepared schedules for capital projects in MS Project monitor and

reported feedback of on-going projects to the Project Engineer and

Managers.

. Assisted Project Managers and others with the Facilities Management

group as pertained to tracking of activities, follow up and

expediting.

Engineering and Facility Support:

. Prepared Asset Registration Forms for many completed projects;

initiating capitalization of major capital assets.

. Gathered and entered data from production and facility equipment into

an Excel database.

. Documented building drawings for consultant evaluation

. Prepared spreadsheets, charts, and graphs required for reports and

compiled Global reports.

. Supported benchmarking initiatives with Global team.

. Assisted the engineering group with project cost estimation.

. Ensured that all work performed in full compliance with current Good

Manufacturing Practice (GMP), Standard Operating Procedures (SOP's)

and in accordance with established Safety Standards.

Undergraduate Projects

Capstone Plant Design (Natural Gas Extraction-Worley Parsons)

2014

. Project entailed a preliminary design of an offshore platform made to

take natural gas extracted from the sea, and boost the gas pressure so

that it reaches an onshore facility at the required receipt pressure.

. Major contributions include:

> Designing the Multi-Stage Compression unit needed to boost the

gas pressure.

> Determining the amount of fuel required to sustain power for all

equipment on the platform.

> Determining CAPEX for entire project.

. Project was presented to the client through a Power Point presentation

as well as documented in a formal report.

Education and Credentials

University of Toronto

2010-2015

B.A.Sc. in Applied Science (Chemical Engineering)

Engineer In Training (EIT) Member since

2015

Completed PPE Exam

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