Summary
Overview
Work History
Education
Skills
Websites
Certification
Publications
References
Timeline
Generic

Holden Tuscano

Scarborough,ON

Summary

Quality Assurance/Regulatory Affairs professional with hands on experience backed with educational expertise. Half a decade of experience implementing high-quality standards with suppliers and distributors in accordance with quality safety and regulatory body. GXP, ISO implementation and training to represent RA department. Strong Health Canada and FDA experience with Policies and Personnel. Extensive experience and subject matter expertise in Quality Assurance and Regulatory Affairs. Ability to ensure compliance, manage relationships, drive improvement, and lead cross-functional teams with additional Data integrity/Intelligence skills is indicative of a well-rounded professional in this field.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Co-Ordinator

AURORA NUTRASCIENCE
12.2022 - Current
  • Coordinated regulatory submissions and approvals for NHP in compliance with FDA and Health Canada Standards. Developed efficient new product launch and sample submission process flow with more than 80% success rate.
  • Monitoring regulatory and external environment, to anticipate proactively affecting relevant changes to regulatory standards, achieving conformance up to 95%.
  • Over four years experience in providing technical input with quality compliance and Regulatory marketing for successful product launch and Product development.

SENIOR QUALITY CONTROL

AURORA NUTRASCIENCE
03.2022 - 12.2022
  • Maintaining oversight of QMS projects with 75% less redundancy. Implementation of Regulatory projects within assigned area for efficient workflow design.
  • Interfaced with suppliers, inspectors and clients to resolve outstanding non-conformance issues prior to shipment and audits. Successfully developed query file consisting of Audit reports, SOP, Regulatory policy to minimize communication gap.
  • Performed and coordinated audit inspections and determined quality assurance testing models of raw materials and finished products while increasing testing rate by 40%.

QUALITY ASSURANCE LEAD

LAZAR GOURMET FOODS
12.2020 - 02.2022
  • Successfully implemented HACCP principles and proper CCPs, resulting in 70% reduction in customer complaints related to product safety and quality.
  • Improved plant GMP and CGMP compliance by conducting regular audits and training sessions, resulting in 95% compliance rating.
  • Lead in Liaising with CFIA inspector and reducing non-conformance comment rate by 85% and having non-CA warning throughout fiscal year.
  • Investigated variances, performed root-cause analysis and documented corrective actions to resolve complications.

PHARMACY ASSISTANT

METRO
02.2020 - 11.2020
  • Organized client information into correct profiles while maintaining confidentiality under Pharmacovigilance program of Ontario.
  • Strong Data-base management experience of prescribed and non-prescribed drugs with all Regulatory information using Kroll and McMahon software
  • Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medication-specific issues.

Education

Bachelor of Science - Biotechnology

CENTENNIAL COLLEGE
Toronto, ON
12.2021

Bachelor of Science - Biotechnology

K. C. COLLEGE, UNIVERSITY OF MUMBAI
India
03.2019

Skills

  • GXP/ISO Training
  • Internal/GMP/FDA Audits
  • Document Control/Review
  • Audit Compliance
  • EMOTIONAL INTELLIGENCE
  • ADAPTABILITY
  • LEADERSHIP
  • COACHABLE

Certification

  • ISO 9001:2015
  • QMS, HACCP, SOP
  • Product VERIFICATION (USP)
  • ISPE- GAMP
  • DOCUMENT CONTROL
  • 3M ATP swab and Plate reader certified technician

Publications

Extracting dye-pigment producing actinomycetes and studying its anti-bacterial applications In Microbiology laboratory (E-ISSN: 2347-7520)

References

Sherry Nezarati, Quality Supervisor, Aurora Nutra science, (204) 599-9531, Quality@auroranutrascience.com Ansu Shilan, HACCP Co-Ordinator, Lazar Gourmet Foods, (647) 677-1955, annsu4u@gmail.com

Timeline

Regulatory Affairs Co-Ordinator

AURORA NUTRASCIENCE
12.2022 - Current

SENIOR QUALITY CONTROL

AURORA NUTRASCIENCE
03.2022 - 12.2022

QUALITY ASSURANCE LEAD

LAZAR GOURMET FOODS
12.2020 - 02.2022

PHARMACY ASSISTANT

METRO
02.2020 - 11.2020

Bachelor of Science - Biotechnology

CENTENNIAL COLLEGE

Bachelor of Science - Biotechnology

K. C. COLLEGE, UNIVERSITY OF MUMBAI

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Holden Tuscano