Summary
Overview
Work History
Education
Skills
Certification
Volunteer Experience
Training
Timeline
Generic

JENNIELEE TABUJARA

Toronto,ON

Summary

Individual with 10+ years' experience in Quality Control and Quality Assurance in pharmaceutical regulatory environments, with success in obtaining GMP and ISO certifications for a Licensed Producer of medical cannabis

Overview

12
12
years of professional experience
1
1
Certification

Work History

VP, Regulatory Affairs

Weed Me Inc.
11.2022 - Current
  • Cultivated strong relationships with key stakeholders, including customers, vendors, regulators, and community leaders to promote collaboration and long-term success.
  • Demonstrated proficient leadership skills to motivate employees and build competent teams.
  • Collaborated with senior management to develop strategic initiatives and long term goals.
  • Hired and managed employees to maximize productivity while training staff on best practices and protocols.
  • Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
  • Performed internal audits to maintain operating procedure and regulatory standards compliance.
  • Wrote, reviewed and approved documents to preserve quality assurance.
  • Facilitated training sessions on quality assurance methodologies, equipping staff members with essential skills for success in their roles.
  • Promoted a culture of accountability within the team through regular performance evaluations and feedback sessions.

Director, QA

Weed Me Inc.
03.2018 - 11.2022
  • Health Canada-approved Quality Assurance Person with Security Clearance
  • Champion the transition from a purely paper-based batch record system to an electronic batch record platform
  • Establish and enforce GAP, GPP, and quality assurance standards, providing technical and regulatory input for growing, packaging, and production
  • Coordinate all key product quality issues including complaint handling, investigations on deviations or incidents, and implementing corrective and preventive actions (CAPA) to close out quality and security gaps
  • Coordinate external testing of cannabis products
  • Act as the key point of contact during all third-party inspections or audits, including Health Canada or provincial boards
  • Oversee an effective sanitation program to ensure production, packaging, labeling, and storage activities are conducted under sanitary conditions
  • Review and approve Standard Operating Procedures (SOPs) for all processes
  • Train staff in SOPs to ensure the correct implementation in operations and regulatory compliance
  • Review batch records, analytical reports, and Certificate of Analysis (CoA) of each product batch before its release for sale
  • Plan, conduct, and manage the activities to ensure compliance with internal and external standards and requirements.
  • Implement and maintain preventative control plans for cannabis 2.0 products (cannabis extracts, edible cannabis)

QA ASSOCIATE

Bite Beauty
09.2017 - 03.2018
  • Meet with and/or interview staff to author and edit standard operating procedures (SOPs) in clear and concise language
  • Aid in implementation of QMS
  • Maintain document control, create and maintain excel databases
  • Create user documentation for a variety of material, including forms, work instructions, SOPs, flow charts and other work aids
  • Ensure technical verbiage is easy to understand by the lay person
  • Review and approve GMP documents (batch records, stability reports and other related documents)
  • Submit work to stakeholders for feedback
  • Review documents as necessary and proofread for grammar and spelling
  • Initiate and prepare deviation reports
  • Support CAPA and Change Control Systems.

QA SUPERVISOR

MedReleaf Corp.
06.2016 - 06.2017
  • 200+ batch processing records reviewed and prepared for release for sale by Quality Assurance Person
  • 70+ Security Clearance applications reviewed and submitted to Health Canada
  • 25+ Licensing amendments and notifications prepared and submitted to Health Canada
  • Ensure compliance with Health Canada's Access to Cannabis for Medical Purposes Regulations
  • Conduct internal audits and self inspections against SOPs, ISO standards and GMP guidelines
  • Participate in Health Canada inspections, as well as ISO and GMP audits
  • Perform corrective actions and prepare responses to Health Canada inspection reports, and ISO and GMP audit reports
  • Author and revise SOPs pertaining to the manufacturing processes and Quality Management System (CAPAs, Change Controls, Vendor Qualification)
  • Review client complaints, product/process deviations, change controls
  • Implement and maintain ICH GMP Q7, ISO 9001, ISO 14001 management systems.

QC AND DOCUMENT CONTROL COORDINATOR

MedReleaf Corp.
06.2015 - 06.2016
  • 300+ SOPs revised and uploaded
  • Maintain QA records: Audit Reports, Preventative and Corrective actions and associated information
  • Review batch production records for completeness and accuracy
  • System administrator for document control software.

QC REVIEWER

Pharma Medica Research Inc.
05.2013 - 05.2015
  • 250+ Certificates of Analysis reviewed and approved for use
  • Ensure that all reports and accompanying data are accurate, correct, and acceptable according to study protocols and relevant SOPs prior to submission to QA
  • Review all raw data, sample and instrument logbooks and ensure compliance with GLP and ISO guidelines
  • Generate data tables and compile reports in accordance with protocols and input from department staff using Microsoft Word and in-house LDMS software
  • Interact with department staff to acquire information for report writing and auditing purposes and present to management any information regarding deficiencies
  • Follow up on corrective action indicated on study/validation audits.

QC REVIEWER ASSISTANT

Pharma Medica Research Inc.
05.2012 - 05.2013
  • Maintain a system for organizing laboratory files and forms
  • Maintain a system for tracking, filing, managing, and archiving of all laboratory documents, raw data and reports
  • Ensure PMs and Laboratory Management are kept up to date regarding QC audits of raw data, instrumentation, and calibration within the laboratory through both oral and written reports on a daily basis.

Education

Master of Science - Food Safety And Quality Assurance (FSQA)

University of Guelph
Guelph, ON
09.2024

BACHELOR OF SCIENCE - Biological Sciences

University of Guelph
04.2012

Skills

  • ACMPR
  • Cannabis Regulations
  • Cannabis Act
  • ISO 9001
  • ISO 14001
  • Decision-Making
  • Relationship Building
  • Team Leadership

Certification

  • CHA, ASQ, 03/2016
  • Course on Research Ethics based on the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2: CORE 2022)


Volunteer Experience

Mount Sinai Hospital, SUMMER VOLUNTEER, Mount Sinai Allograft Technologies, Pathology and Laboratory Medicines, 04/2009, 08/2011

Training

Ensur, BioTrack, Record Keeping in Compliance with MMPR, LIMS/LDMS Software, AmegaView, Report Writing

Timeline

VP, Regulatory Affairs

Weed Me Inc.
11.2022 - Current

Director, QA

Weed Me Inc.
03.2018 - 11.2022

QA ASSOCIATE

Bite Beauty
09.2017 - 03.2018

QA SUPERVISOR

MedReleaf Corp.
06.2016 - 06.2017

QC AND DOCUMENT CONTROL COORDINATOR

MedReleaf Corp.
06.2015 - 06.2016

QC REVIEWER

Pharma Medica Research Inc.
05.2013 - 05.2015

QC REVIEWER ASSISTANT

Pharma Medica Research Inc.
05.2012 - 05.2013

Master of Science - Food Safety And Quality Assurance (FSQA)

University of Guelph

BACHELOR OF SCIENCE - Biological Sciences

University of Guelph

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