Contact Information

T: 905.363.1182 x.217
F: 905.542.7981

TF: 1.877.877.5152 x.217
M: 416.312.4347

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Project Manager, Quality Services

Melisa is an experienced quality assurance professional with over 10 years in the pharmaceutical, natural health product, and medical devices industries. She is a skilled auditor who has generated increased compliance ratings. Her experience combined with her education and training, make Melisa a valued asset to both Q&C and our clients.

Skills & Highlights

Quality Assurance/Quality Control

  • Prepared quality system reports for results tracking to evaluate gaps and improvement initiatives
  • Wrote Standard Operating Procedures (SOPs) to define standards of practice for compliance to Health Canada Good Manufacturing Practices (GMP), Health Canada Natural Health Products GMP, Canadian Medical Device Regulations, and Marihuana for Medical Purposes Regulations
  • Performed quality system document control activities (e.g., document change control, scheduled periodic compliance review, and document archive)
  • Investigated and evaluated non-conformances to determine risk assessment, root causes, the effect on product quality, affected materials disposition, and corrective/preventive actions
  • Maintained, implemented and executed follow-up on all Corrective And Preventive Action (CAPA) elements including change control and responding in a timely manner to internal and external customers
  • Performed product releases for Canada
  • Reviewed master manufacturing documents, master packaging documents, labelling specifications, finished product specifications, raw material specifications, stability reports & data, and transportation reports/validations to assess product compliance to Canadian regulatory requirements for release in Canada
  • Reviewed batch records for drug (DIN) & Natural Health Products (NPN)
  • Reviewed raw laboratory data in relation to finished product test results
  • Managed incoming materials inspection program and vendor evaluation program
  • Coordinated annual full confirmatory testing of drug and NHPs per Canadian regulations
  • Supported Stability Program by reviewing and approving stability protocols and data reports for Canada
  • Reviewed Annual Product Quality Review (APQR) for compliance to Canadian GMP
  • Product recalls:
    • Managed product recall storage compliance, recall reporting, and recall disposal (incineration) for drug product
    • Performed mock recall reconciliations
  • Managed cold chain to maintain temperature control of products within required ranges during storage and shipping
  • Managed cold chain to maintain temperature control of products within required ranges during storage and shipping per GUI-0069 Guidelines for Temperature Control of Drug Products During Storage and Transportation
  • Completed Natural Health Products Quality Assurance Report (QAR) for manufacturer license application
  • Managed quality system compliance for 2 shift packaging operations handling Over-the-Counter (OTC) licensed drug products, natural health products, and medical devices
  • Supervised Quality Assurance Specialists, including one stationed at client distribution facility.
  • Managed ISO:13485 Quality System for IVDD (in-vitro diagnostic device) products
  • Approved by Office of Controlled Substances (OCS) Health Canada for first ranking Alternate Qualified Person In Charge (A/QPIC) after QPIC:
    • Managed controlled substances vault and cage distribution operation
    • Reviewed and approved scripts for order processing only for authorized institutions under the applicable controlled substance regulation with reference to licensed dealers (QPIC, A/QPIC, signing authority), pharmacists, physicians, OCS circular letters, and retraction notices
    • Performed various distribution activities for controlled substances such as receiving, order picking & checking, daily cycle count, inventory count discrepancy investigation
    • Executed chain of signature process for shipping controlled substances in compliance with regulations
    • Reported controlled substance inventory discrepancy (loss or theft) within 10 days of discovery per OSC requirements
    • Authorized receipt of controlled substance customer returns & refusals

GMP Training

  • Designed, implemented, and maintained a system to track and record employee training requirements and completions
  • Executed full quality system training at distribution sites, including Canadian GMP

On-Site Consulting/Project Management

  • Completed Health Canada remediation activities to achieve GMP compliant rating for a division of a large pharmaceutical company
  • Project management and quality oversight for a company applying to be a licensed producer under the Marihuana for Medical Purposes Regulations

Training

  • Implemented and maintained a system to track and record employee training requirements and completions
  • Executed full quality system training at distribution sites, including Canadian GMP
  • Executed GMP training programs for wholesaler and importer/distributor
  • Completed training on Good Production Practices – Marihuana for Medical Purposes

Auditing

  • ASQ CQA (American Society for Quality - Certified Quality Auditor)
  • Hosted Health Canada Drug Establishment License GMP inspection for importer, distributor, wholesaler, and packager/labeler
  • Hosted Health Canada Medical Device inspection for importer & distributor
  • Responded to audit findings, and implemented corrective actions in a timely manner
  • Performed GMP manufacturer, importer, wholesaler, and packager/labeler self-inspection and gap inspection audit
  • Performed audit to Canadian Medical Device Regulations for purchasing due diligence and gap identification purposes
  • Performed self-inspection audits for Canadian Medical Device Regulations
  • Performed gap inspection audits for Natural Health Products GMP importer and manufacturer
  • Performed gap inspection audit for Good Production Practices - Marihuana for Medical Purposes Regulations (SOR/2013-119)
  • Performed foreign (non-MRA) API manufacturer audits to ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • Completed Good Pharmacovigilance Practices (GVP) self-inspection
  • Performed audit of foreign packaging component supplier to ISO 15378 Primary Packagin Materials for Medicinal Products - Particular Requirements for the application of ISO 9001:2008 with Reference to Good Manufacturing Practice (GMP)
  • Performed audit of foreign packaging component supplier to ISO 9001: Quality System & USP <660> Containers - Glass
  • Performed inspection of Canadian third party storage and distribution warehouses to GMP standards
  • Supervised team of 6 Quality Inspection Auditors

Validation

  • Wrote protocols for qualification/validation, calibration, and operations and maintenance of production equipment, including change controls
  • Performed qualification/validation and calibrations on laboratory equipment (pipettes, balances, spectrophotometer, pH meters, microplate reader)
  • Supervised temperature data logger system installation and qualification for 21CFR11 compliance

Computer Skills

  • Inventory management software: AS400, SAP, Viaware, other custom
  • Quality system software: CatsWeb (AssurX), Compliance Wire (Eduneering), Documentum GDMS (EMC Corp.), Kintana PPM (HP), PeopleSoft (Oracle), MasterControl

Education

  • Pharmaceutical Technology Diploma, Quality Assurance and Quality Control, Toronto Institute of Pharmaceutical Technology (TIPT), Toronto Ontario
  • Bachelor of Science, Biological Sciences, University of Guelph, Guelph Ontario

Continuing Education, Career Development

  • Introduction to Project Management
  • ASQ CQA (American Society for Quality - Certified Quality Auditor)
  • Overview of CMDRs (Canadian Medical Devices Regulations) and CMDCAS (Canadian Medical Devices Conformity Assessment System)
  • Organizational Behaviour
  • Costs and Management Accounting
  • Process Approach to Auditing
  • Effective Cleaning Validation Practices
  • ISO 13485:2003 Essentials Course
  • FDA Medical Device Workshop, HCIA (Health Care Industries Association) in conjunction with DSMICA (Division of Small Manufacturers, International and Consumer Assistance)
  • Establishing Supplier Audit & Vendor Qualification Program