Contact Information

T: (905) 363-1182 x 235
F: (905) 542-7981
C: (647) 273-9244

TF: 1 (877) 877-5152 x 235
E: nconsiglio@qualityandcompliance.com

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Nicole Consiglio is a seasoned consultant with over seven years of experience in the Quality Assurance and Regulatory fields. Capable of prioritizing multiple projects to meet strict deadlines while maintaining a high level of accuracy, Nicole works effectively on a team and/or independently. She strengthens the QCR team with her outstanding oral and written communication skills.

Skills and Highlights

Quality Control (QCO) / Quality Assurance

  • Managed Quality Systems for importers, including:
    • Ongoing stability programs
    • Change controls
    • Self-inspections
    • Quality agreements
  • Completed triage, investigation and closure of complaint files for drugs, natural health products (NHPs), medical devices and cosmetics
  • Investigated and managed closure of deviations, non-conformances and corrective and preventive actions (CAPAs)
  • Reviewed and closed high volumes of adverse event (AE) and adverse drug reaction (ADR) files for USA dietary supplements and NHPs
  • Handled post-recall activities for drug products
  • Set up quality assurance systems for importers
  • Prepared and reviewed annual product quality reviews (APQRs) using foreign supplier reports and local quality data
  • Completed Master manufacturing/batch record review and lot release
  • Completed Health Canada audit responses
  • Performed post-recall activities for drug products
  • Completed temperature mapping study for NHP storage warehouse

Technical Writing

  • Developed, reviewed and updated Good Manufacturing Practices (GMP) Standard Operating Procedures (SOPs) ensuring regulatory requirements were met

Regulatory

  • Completed Drug Establishment Licence (DEL) applications and maintenance
  • Assessed and filed updates to Generic Regulatory Dossiers (Post-NOC changes) in Common Technical Document (CTD) and eCTD format
  • Completed regulatory submissions to Health Canada for drugs, NHPs, and medical devices
  • Completed New Substance Notifications (NSNs)
  • Completed NHP site licence applications
  • Completed NHP product licence applications (compendial and non-traditional)
  • Performed Drug, NHP and Cosmetic label reviews

Validation

  • Assisted in the development of computer system validation documentation (user requirements specifications and IQ/OQ/PQ scripts)
  • Executed computer system validation scripts

Auditing

  • Participated in conducting audits of third party facilities
  • Assisted in preparation for Health Canada GMP audits

Computer Skills

  • Microsoft Office (Word, Excel, PowerPoint)
  • Document Management Systems
  • NuGenesis
  • SAP
  • Trackwise
  • LIMS
  • Sharepoint

Education

  • Regulatory Affairs Post-Graduate Certificate – Humber College
  • Bachelor of Science – University of Guelph

Continuing Education

  • Technical Writing Course, Q&C
  • Current GMP Training
  • Introduction to Deviations and Change Control
  • Investigation, Excursion and CAPA (concepts)
  • LIMS - Overview and External Customer Modules
  • Workplace Health and Safety
  • Sharepoint Course, BHS Consultants
  • Email Dos and Don'ts, Progressive Training
  • Time and Workload Management with Outlook, Progressive Training