Prasanna Wijayakoon Email & Phone Number

Cambridge, Ontario, Canada

-Coordinates the generation/revision of documents such as specifications for API, excipients, packaging components, bulk product, in-process testing, finished product, and stability testing, as well as the stability protocol as per established guidelines and internal SOPs.-Prepare method verification/transfer protocols and their corresponding reports.-Manage all SAS operation documents such as LIMS logbooks, working specs both in paper and in electronic formats.Testing of primary and secondary packaging components.-Provides support to the Stability Coordinator, assisting in stability program activities, such as revising stability protocols and specifications in LIMS.-Create/update test methods and SOPs.-Assist various deparments in preparing documents for CDMO regulatory submission.-Communicate with Project Management, customer and Quality teams.-Follow GMP and regulatory requirements, and ensure quality standards are met-Observe and support all safety guidelines and regulations using SDS, perform 5S and maintain audit readiness of responsible work areas.-Department metrics and monthly activity reports created using Power BI/Excel and presented to management team. -Other related duties as assigned

Cambridge, On

-Physical and chemical testing of finished product, raw materials and components. The testing includes but is not limited to routine testing, testing for QCPs, QATPs and intermediate precision tests for method development.-STARLIMS responsibilities: Log in and receipt of samples, pulling of stability samples and building as well as reviewing Stabilty Study Protocols. Currently trained in QC Tech, Stability Tech and Stability Coordinator roles. -Equipment usage: HPLC instrumentation, Viscometer, Osmometer, Melting range apparatus, Optical Comparator, Optical rotation apparatus, PAL Expert Tensile Force machine, DMMF etc. -Responsible for the clean-room sampling of APIs, excipients and components for Stability and PD.-Data analysis: Developed metrics reports and trends analysis using Power BI.

Cambridge, On

-Responsible for the running of equipment producing dental anesthetic in accordance with SOPs with an emphasis on overall equipment efficiency and reduction of waste. -Preparation of components for dental cartridges and testing of Finished Products with a strict adherence to GMP and regulatory requirements.

Cambridge, On

-Performed physical and chemical testing for a variety of dental anesthetic and healthcare products while following GMP and ensuring quality standards were met, Extensive usage of STARLIMS for the Stability and Analytical Services division.-Responsible for a variety of tasks including but not limited to data review, data collation for R&D and QA, product maintenance in stability chambers and resource calculations for management. Updated various SOPs and documents via or using an electronic quality system.

Cambridge, On

-Performed testing and assisted with the pulling, labeling and transfer of samples with a high degree of precision. -Responsible for the daily maintenance of chart/stability records for stability chambers.

-Completed tickets for designs based on Figma using Tailwind, React and AItechnologies.-Worked with daily standups using Jira to update ticket status and identify blockers.-Worked cohesively with developers as part of a team for the Skill Garage bootcampwebsite

- Developed websites with clean designs and responsiveness across different viewports.- Created full-stack web applications with current frameworks and packages.- Provided on-call support for coding issues and bugs. - Contributed to open source software using the MERN stack.

Kitchener, Ontario

-Conducted a variety of experiments on smoking products which tested for chemicals such as tar, nicotine, glycidol, ethylene glycol, polynuclear aromatic hydrocarbons, volatiles etc. -Responsible for the preparation of extraction solutions used during smoking, impingers, ice baths and other glassware as well as the post smoking samples for analysis.