Summary
Overview
Work History
Education
Skills
Reference
Timeline
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Nishi Shah

Summary

An ambitious professional with strong technical and interpersonal skills with over 5 years of experience in Pharmacy, who is detailed oriented, highly organized, able to prioritize and who aims to add value to a range of stakeholders. I currently studied Post Graduate diploma for Quality assurance and regulatory affairs with hand on experience of regulations of Medical devices. and looking to expand into a high performing, fast paced and progressive team where I can utilize my passion and my skills to provide quality solutions.

Overview

8
8
years of professional experience

Work History

Pharmacy Assistant

Shoppers Drug Mart
08.2022 - Current
  • Prioritizing and dispensing prescribed medication received via multi-channels: face-to-face, fax and online; Data entry, dealing with third party issues; Filling and dispensing of patients medication;
  • Blister pack packing
  • Maintenance of Pharmacy stock through inventory control systems and sorting through expired products from active stock.(Using FIFO method);
  • Completed regulatory compliance tasks, such as logging controlled substances, upholding legal requirements in pharmaceutical practices.

Regulatory Affairs Associate

MF LICENSE AND REGULATORY CONSULTANTS (MFLRC)
04.2024 - 04.2024
  • Preparing validation document for Cannabis Company

● GMP compliance

● Labeling Compliance

● Prepare documents for Regulatory submissions for Natural health products and Medical devices

and Cannabis.

● Support Communication with the regulatory agencies

● Review, maintain new or revised Standard Operating Procedures

● Assist in writing, reviewing, maintaining and approving all quality

● documents such as SOP's/protocols/certificates etc


Regulatory Affairs Associate

ANZ Pharmaceuticals
03.2019 - 09.2021
  • Identify and interpret relevant regulatory guidelines.
  • Assist in obtaining government approval for drugs and medical devices
  • Updating and maintaining regulatory databases
  • Ensuring compliance with all regulatory requirements and Maintaining regulatory documentation database
  • Managing international regulatory issues, helping plan strategies to get products approved by the government, and engaging in post-marketing surveillance of products.
  • Coordinating and completing reports required by federal agencies, maintaining complex files and electronic document management systems, and working with project teams to obtain approval for company products

Medical coder

Advantmed Private Limited
09.2016 - 03.2018
  • Examine and be mindful of prescribed drug interactions; Cross-checking with patients about each medication, its dosage details and its intake; Explaining side effects of medication(s); Medical coding for external pharmaceutical company requirements

Education

Post Graduate Diploma for Quality Assurance and Regulatory Affairs -

Academy of Applied Pharmaceutical Sciences (AAPS
Toronto, ON
03.2024

Pharmacy Technician -

Kauri Academy
Auckland , New Zealand
09.2019

Bachelor of Pharmacy -

L.J Institute of Pharmacy
Gujarat, India
06.2017

Skills

  • Good Clinical Practices (GCP)
  • Good Manufacturing Practices (GMP)
  • GDP(Good Documentation Practices)
  • Corrective and Preventive Actions (CAPA)
  • eCTD AND SOP (Standard Operating Procedures)
  • FDA Regulations , ISO Standards, ICH, EU and Health Canada Guidelines
  • Quality Management Systems
  • Regulatory Submissions and Regulatory guidelines
  • Change Control Management
  • Validation Procedures
  • Data Analysis
  • Product Labeling
  • Product Licenses and IFU listing
  • MDEL and MDL
  • Quality Assurance
  • Clinical Trials
  • Auditing
  • Bio analytical Skills
  • Proven ability to build rapport and Excellent written and oral communication with various stakeholders
  • Quick learner with ability to adapt quickly to new information and team environment
  • Sound knowledge of MS Office Application
  • Problem Solving
  • Time Management

Reference

Available upon Request

Timeline

Regulatory Affairs Associate

MF LICENSE AND REGULATORY CONSULTANTS (MFLRC)
04.2024 - 04.2024

Pharmacy Assistant

Shoppers Drug Mart
08.2022 - Current

Regulatory Affairs Associate

ANZ Pharmaceuticals
03.2019 - 09.2021

Medical coder

Advantmed Private Limited
09.2016 - 03.2018

Post Graduate Diploma for Quality Assurance and Regulatory Affairs -

Academy of Applied Pharmaceutical Sciences (AAPS

Pharmacy Technician -

Kauri Academy

Bachelor of Pharmacy -

L.J Institute of Pharmacy
Nishi Shah