Ravie Samaroo Email & Phone Number

Toronto, Ontario, Canada

• Developed and implemented OCS Supplier Corrective Action Request (SCAR) schema in collaboration with business stakeholders• Lead the OCS SCAR program implementation and communications with OCS vendors • Developed and lead OCS remote audit program in response to COVID pandemic• Ensured the finished products shipped to the OCS from LPs met both the OCS and Health Canada standards/regulations through the execution of periodic reassessment audits at the OCS and reinforcing OCS requirements by educating the OCS vendor base on OCS requirements. In doing so I consistently ensured the quality and safety of the product shipped to OCS customers• Assisted in the preparation of reports for stakeholders regarding complaints/recalls/non-conformances, and aided in the identification of quality trends to be reviewed, investigated, or actioned• Established and cultivated strategic relationships with OCS suppliers by acting as a facilitator and liaison for all business concerns from vendors such as product call queries and quality related issues• Assisted in the collection and provision of data to Insights team for Quality Metrics

Toronto, Ontario, Canada

Ensured the finished products shipped to the OCS from LPs met both the OCS and Health Canada standards/regulations through the implementation of vendor qualification audits at the OCS and reinforcing OCS requirements by educating the OCS vendor base on OCS requirements. In doing so I consistently ensured the quality and safety of the product shipped to OCS customersPerforming periodic reassessment audits of LPs and initial qualification audits of LPs • Developed the OCS Vendor Management Process, Quality Vendor Risk rating system and auditing approach to triage vendor audits and assess risks posed to the OCS business. Developed and implemented the OCS document control, document management and supplier corrective active programs Assisted in the analysis of product/packaging quality and compliance using performance metrics and the creation of reports for OCS Warehouse Quality Inspections on an ongoing basis Performed root cause analyses on product quality concerns/trends and implemented necessary corrective and preventative actions by working directly with OCS licenced producer partners and internal stakeholders• Prepared reports for OCS management stakeholders summarizing the risks and opportunities posed by licenced producers (LPs) Developed OCS audit report structure, risk rating schema, audit matrix schema and audit frequency metricsCreated and implemented the vendor category expansion process and risk assessment for vendor category expansions

Canada

• Reported on vendor compliance status to the BD – Canada business through the use of KPIs such as claims, right the first time order shipping and training compliance • Verified vendor processes, procedures and systems ensuring the adherence and recommendations to regulatory and BD – Canada standards such as GMP, Medical Device Regulations and ISO 13485:2016 standards• Actively worked with vendors to increase awareness and conformance to business requirements such as tool calibration providers, third party warehousing and translation service vendors by training vendors on regulatory requirements • Performed three QA audits ensuring organization was compliance to Canadian Food and Drugs Act and Regulations, ISO 13485:2016, CMDR and corporate requirements. • Reviewed and maintained records of reported quality incidents and CAPA investigations, performed over twenty five non-conformance investigations, corrections, and oversaw the execution of five CAPAs. • Prepared sites and hosted QA audits for over six regulatory compliance audits such as Health Canada Medical Device compliance audits, Cells Tissues and Organs (CTO), drug audits and internal audits by preparing pre-submission packages, training of site personnel on audit processes and performing pre-audit reviews of the Quality System. • Assessed vendors and product metrics/KPIs for Vendor Management Initiatives by overseeing supplier corrective action program (SCAR), ensured vendors performed thorough investigations, implemented corrections and reviewed key performance indicator data during monthly and weekly reviews with vendors. • Developed, lead and implemented four separate Quality Management System (QMS) compliance project implementations for Canadian Medical Device regulations and ISO 13485:2016 compliance and lead merger of three distinct QMS through the merger of over twenty different processes into a single QMS.

Toronto, Ontario

• Implemented and managed multiple high priority projects with competing deadlines such as a design control and good documentation practices• Assisted in the development of design control processes, procedures, Medical Device File creation and design reviews in compliance with 21 CFR Part 820 requirements • Created ISO 13485: 2016 complaint processes • Assisted in the implementation and maintenance of an Electronic Quality Management System and training system

Mississauga

•Participated in CAPA process and implementation of QA and QC procedures and processes•Implemented and coordinated regulatory compliance projects such as unique device identifiers•Coordinated and implemented software validation and verification for regulated processes •Performed formal process mapping and risk assessments of company processes to determine potential risks and failures associated with processes and impacts of future projects on internal processes

Richmond Hill

• Retrieved, compiled and summarized data for annual product reviews • Created complaint investigation acknowledgement letters and return packages• Triaged complaint reports to identify adverse drug reactions and potential drug overdoses• Gathered data from SAP and internal databases for complaint investigation• Aided in the compilation of response packages to FDA warning letters and unpublished letters• Performed administrative tasks such as filing, scanning, copying and printing of relevant paperwork• Conducted batch document reviews to identify issues with batches currently on the market• Created annual product review Power Point presentations for executive review

Mississauga

•Organized and properly stored client samples based on sample type and desired retention time•Responsible for tracking sample movements into and out of storage areas and delivery to clients•Properly disposed of hazardous materials and waste samples in accordance to environmental regulations

Oakville

•Acted as a liaison between the company and electronic medical record software vendors •Independently assembled, shipped and monitored the distribution of promotional materials to field sales representatives across Canada•Retrieved, analysed and compared competitor drug costs with company productsCreated presentation graphs, spreadsheets and figures

Ontario Canada

•Prepared and verified bottle orders and followed up with project managers in a timely manner•Responsible for maintaining daily verification records according to standard operating procedures•Collaborated with supply chain management staff and supervisors to organize inventory•Processed and prioritized orders based on geographic location, carrier type, urgency and special requests•Organized and properly stored client samples based on sample type and desired retention time•Responsible for tracking sample movements into and out of storage areas and delivery to clients•Properly disposed of hazardous materials and waste samples in accordance to environmental regulations

Mississauga

• Installed, maintained and monitored laboratory instruments, such as, an automated scanning microscope, oxygen, nitrate and salinity probes• Responsible for calibration of instruments and maintenance of calibration records • Performed daily data collection of instrument readings • Effectively summarizing and presented data collected in a usable, easy to read format• Created and organized a sample inventory for coralline algae samples• Edited images for research purposes using Adobe® Illustrator to observe the correlation between temperature data and growth layers• Prepared samples for analysis in accordance with set deadlines

Regulatory Affairs And Quality Operations (Raqc), Pharmaceutical Sciences

Areas of Study: Biotechnology and Biopharmaceuticals Production Forumaltion and Marketing Introduction to Quality Assurance Introduction.

H.B.Sc, Biology/Biological Sciences, General

Activities and Societies: Rotaract Club UTM• Earned an Honours Bachelor of Science; Double Majoring in Biology and Environmental Science.

Highschool Diploma, Chemistry, Biology And Mathematics