Summary
Overview
Work History
Education
Skills
Languages
Timeline
Raziyeh Mahdavi

Raziyeh Mahdavi

North Vancouver,BC

Summary

Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Overview

6
6
years of professional experience

Work History

QA Manager (Qualified Person) & RA Manager:

Vitabiotics Ltd (Vitabiotics Pharmed/Vitaaria Co.)
10.2020 - Current
  • Oversee and coordinate regulatory inspections and internal audits. Prepare comprehensive responses to any findings from these inspections/audits and ensure effective implementation and closure of corrective actions
  • Manage Customer Complaint Investigation process to effectively identify, prioritize, and address major product quality issues. Lead process improvement teams to resolve these issues and ensure timely, value-added deliverables for Annual Product Review program.
  • Lead implementation and enhancement of Quality Systems to ensure compliance and develop metrics to evaluate effectiveness of key Quality KPIs.
  • Communicate with cross functional departments to improve departmental performance and efficiency. Especially with procurement and finance team to select raw materials which meet financial and quality goals and contribute to cost saving initiatives.
  • Oversee supplier management program, reviewing suppliers audit report, and material reviews.
  • Manage Product Stability Program, ensuring efficient preparation of protocols, sample pulls, testing, OOS investigations and approval.
  • Review and approve Regulatory Submissions, Technical Quality agreements, Validation protocols and reports, product development reports and other documents.
  • Liaised with Regulatory Authorities for new product manufacturing licenses, Establishment Licenses and renewals of same.
  • Certify batches of pharmaceutical and natural health products prior to release for sale and placing on market.
  • Lead technology transfer and scale-up operation to manufacture products in-house, and development of robust, stable and effective formulations to be used at 3rd party manufactures.
  • Coordinate development of specifications and analytical procedures in coordination with QC and R&D laboratory.
  • Support QA & RA teams in achieving their personal development goals and ensure each team member properly trained for their roles. Lead and manage QA department, prioritizing safety, quality, and productivity.
  • Assist change control committee for overall reviews of non-conformities, failure investigation, deviations, updating specifications, test procedures and manufacturing processes.

QA & Regulatory Affairs Senior Specialist

Vitabiotics Ltd (Vitabiotics Pharmed/Vitaaria Co.)
07.2019 - 09.2020
  • Reviewed production and packaging batch records.
  • Participated in over 20 supplier qualification and auditing program and ensured their qualification status were reviewed and maintained.
  • Developed and updated SOPs, provided final review of CAPA and GMP procedures, protocols, forms and instructions ensuring timely implementation and compliance to regulatory and Vitabiotics policies.
  • Reviewed government regulatory and corporate policies to ensure that all procedures were current and met requirements.
  • Tracked and reported product complaints to suppliers/manufacturers and follow-up on corrective actions as needed.
  • Assisted in reviewing product and process documentation for assigned projects to ensure compliance with requirements and monitor renewal to strict deadlines.
  • Supported maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information.
  • Took part in marketing activities for packaging or advertising approvals.

Qualified Person

Setaregan Nik Co.
08.2018 - 06.2019
  • Liaised with regulatory authorities for new product manufacturing licenses and renewals of same.
  • Certified batches of Natural Health products prior to release for sale and placing on market.
  • Wrote, reviewed and/or approved SOPs, and other quality documents as required.

Education

Post-Graduate Diploma - Professional Regulatory Affairs

Academy of Applied Pharmaceutical Sciences, Toronto, Canada
07.2024

Pharmacy Licensure - International Pharmacy Bridging Program

Azad University Pharmaceutical Sciences Branch, Tehran, Iran
2017

• Master of Pharmacy - Pharmaceutics

Jamia Hamdard University, New Delhi, India
2014

• Bachelor - Pharmacy

Jamia Hamdard University, New Delhi, India
2012

Skills

    Collaborative

    Problem Solving & Decisive

    Time Management

    Project & Result Oriented

    Attention to Detail

    Adaptable

Languages

English
Full Professional
Persian
Native or Bilingual
Turkish
Professional Working

Timeline

QA Manager (Qualified Person) & RA Manager: - Vitabiotics Ltd (Vitabiotics Pharmed/Vitaaria Co.)
10.2020 - Current
QA & Regulatory Affairs Senior Specialist - Vitabiotics Ltd (Vitabiotics Pharmed/Vitaaria Co.)
07.2019 - 09.2020
Qualified Person - Setaregan Nik Co.
08.2018 - 06.2019
Academy of Applied Pharmaceutical Sciences - Post-Graduate Diploma, Professional Regulatory Affairs
Azad University Pharmaceutical Sciences Branch - Pharmacy Licensure , International Pharmacy Bridging Program
Jamia Hamdard University - • Master of Pharmacy, Pharmaceutics
Jamia Hamdard University - • Bachelor , Pharmacy

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Raziyeh Mahdavi