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

ANKIT MEHTA

Mississauga,ON

Summary

11 to 12 years of GMP, GDP, eQMS & MDSAP experience in various Industries such as Pharmaceuticals, Cannabis & Medical Device. Experienced in working for QA, QC, Technology Transfer & Stability Studies etc. Knowledge of regulations relating to USFDA, Health Canada, Cannabis and ISO 13485. Excellent written and verbal communication skills, confident, articulate, empathic listener and persuasive speaker. Superior multitasking skills with the ability to manage crisis situations.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Senior Compliance Associate

Mint Pharmaceuticals Inc
04.2022 - Current
  • Health Canada Licence Management - Annual renewal of Drug & Medical Device Establishment Licence (DEL & MDEL) including Foreign Site Annex and Table A
  • GMP Compliance - Oversee maintenance of GMP compliance for all foreign site used to manufacture/package/label and test finished drug products and API
  • Audits - Lead and assist regulatory/internal audits for GMP, Pharmacovigilance for drug products and medical devices
  • Perform vendor audits for CMO, GMP testing Labs, 3PL warehouses and vendor/supplier compliance management
  • EQMS Implementation: Review annual product quality reviews, stability, batch records, product label approvals for 9+ products
  • Write, review, approve and maintain vendor quality agreements, audit report and Nitrosamine and eqms audit responses
  • Draft/Analyze customer complaints, identify trends and tendencies, determine the cause, recommend changes based on investigations and trend, write/compile trend analysis data
  • Ensure all standard operating procedures remain up to date and maintain periodic reviews, conduct trainings for all departments related to SOP revisions, compliance issues, GMP, GDP etc
  • Perform annual GMP trainings for site.

Quality Assurance Specialist

Conavi Medical Inc
09.2020 - 03.2022
  • Complaint and CAPA Management: Manage Customer Complaints, CAPA and investigations through Quality Management System and technical documentation and ensure proper retention of records and documents
  • Follow up on investigations and CAPA plans with respective departments and provide trending reports to Director of Quality
  • Device History Records Management: Write, Review, Authorize Device History Records, Physical / Visual Inspections for products, Final Release Reports, Preparation of Guides, Work Instructions and Job Travelers
  • Electronic Quality Management System {e-QMS): Develop and Manage eQMS system on site as ADMIN USER, train staff on eQMS implementation, training needs for respective departments
  • Standard Operating Procedures: Support and ensure all Standard Operating Procedures (SOPs) remain up-to-date and are reviewed on a regular basis
  • Provide input into processes related to ISO 9001, ISO 13485, FDA Quality System Regulation, Health Canada, EU GMP standards to ensure consistency and compliance
  • Regulatory Inspections: Support Regulatory Inspections readiness process oversight and/or preparation of all responses to observations including any CAPA plans required for compliance
  • Support every aspect of Internal audit quality system program from audit planning, implementation, feedback, re-audit as required.

Operational Quality Lead

Hexo Corporation
10.2017 - 09.2020
  • Quality Assurance Person for Site - Health Canada Security Cleared Personnel
  • Document Management: Write, review, authorize Change Controls, Deviations, Risk Analysis, Process Validations, Batch Release, Recalls, Investigations and CAPA effectiveness checks
  • Lead investigations of facility floor issues, including root cause determination to ensure corrective action and set preventive measures
  • Supplier management: Manage all external suppliers by performing external audits and approving all incoming raw materials, process materials, packaging materials and quality agreements with sites, laboratories etc
  • Training: Collaborate and deliver training with all relevant internal functions to ensure compliance with Health Canada Cannabis Regulations.

Quality Control Analyst

Bausch Health Pharmaceuticals
06.2015 - 09.2017
  • Well acquainted with Laboratory instruments and their operation, UV-Vis spectrophotometer, FTIR spectrophotometer, AAS spectrophotometer, GC and HPLC systems
  • Testing of raw materials finished product, in-process, stability, cleaning validation, batch production runs, lot production runs, purified water, environmental and release of materials in-house
  • Developments of in-house methods and validations, generate laboratory testing specifications for final release, trend analysis of stability studies, product development reports and annual product reviews, recognize out-of-specification or out-of-trend results and assist in the completion of lab investigation.

Quality Assurance Associate

lpca Laboratories
05.2011 - 08.2014
  • Analyzed customer complaints, identify trends and tendencies with respect to lot, product, and type of complaint and determine the cause, draft complaint reports, recommend changes based on investigations and trend analysis
  • Evaluated change request for equipment, primary and secondary components, processes, systems and various types of documents, monitor follow up with departments involved, risk analysis for changes required and close changes upon implementation
  • Reviewed and approved product quality failure and non-compliance investigations, deviations and perform follow-up on corrective and preventive actions pursuant to an incident, assist with process optimization, review SOP
  • Stability Program: Implement Stability studies, prepare stability protocols and execute, draft stability reports, trend analysis of data.

Education

Post-Graduate Diploma - Pharmaceutical Quality Assurance & Quality Control in Pharmaceutical & Food Industry

Red River College of Applied Arts, Science and Technology
05.2015

Master of Science - Pharmaceutics

Pacific University
06.2012

Bachelor of Science - Pharmacy

Shivaji University
06.2010

Skills

  • EQMS implementation and ADMIN
  • Standard Operating Procedures
  • Drug Establishment Licence
  • Compliance Management
  • Quality Agreements
  • Deviations
  • Complaints
  • Change Control
  • Stability
  • Nitrosamine Risk Assessments
  • Annual Product Quality Review
  • Audit Management
  • Training Management

Certification

  • Integrated Pest Management Certificate
  • Industry Program in Pharma Regulatory Affairs
  • Canadian Food Safety Certificate

Publications

  • Progeria: An Accelerated ageing Process published in international journal of Pharma and Biosciences
  • Recent trends in Niosomes as Nanocarriers published in Unique Journal Communications, Journal of Pharmaceutical and Biological Sciences
  • Solubility and Dissolution Rate Determination of Rosuvastatin Calcium in different pH Media using UV Visible Spectrophotometer published in lnventi Journals
  • Pharmaceutical Technology, Quantitative estimation of Rosuvastatin Calcium from tablet formulation by Colorimetric method using Cosneasie Brilliant Blue R dye published in lnventi Journals, Pharmaceutical Analysis and Quality Assurance

References

Available upon request.

Languages

English
Full Professional

Timeline

Senior Compliance Associate

Mint Pharmaceuticals Inc
04.2022 - Current

Quality Assurance Specialist

Conavi Medical Inc
09.2020 - 03.2022

Operational Quality Lead

Hexo Corporation
10.2017 - 09.2020

Quality Control Analyst

Bausch Health Pharmaceuticals
06.2015 - 09.2017

Quality Assurance Associate

lpca Laboratories
05.2011 - 08.2014

Post-Graduate Diploma - Pharmaceutical Quality Assurance & Quality Control in Pharmaceutical & Food Industry

Red River College of Applied Arts, Science and Technology

Master of Science - Pharmaceutics

Pacific University

Bachelor of Science - Pharmacy

Shivaji University

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ANKIT MEHTA