Contact Information

T: 905.363.1182 x.245
F: 905.542.7981

TF: 1.877.877.5152 x.245
M: 416.303.4850

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Lead Consultant

Alex Vikhrov is an experienced quality assurance professional with expertise in quality control and quality management of contract-manufactured and imported products. A documentation reviewer with strong organization, time management skills and experience in batch release of a wide range of drug products across different markets (DINs, NHPs, Injectable, solid dosage form, transdermal systems, gels, OTC, branded, generic). Demonstrates leadership in projects with a strong track record for delivering successful product launches. He is an enthusiastic, versatile team player with strong interpersonal, written and oral communication skills, who promotes collaboration and initiative within your team.

 

Skills & Highlights, Big project

Quality Control (QCO)

  • Expert in quality control and batch release process for imported and contract-manufactured products

  • Review of Executed Batch Records and manufacturing documentation

  • Experienced in developing batch release and related quality control procedures

  • Experienced in review of manufacturing and shipping deviations, and making decisions on the course of investigations, risk-mitigation and product disposition

  • Management of annual and periodic confirmatory testing programs for imported products

  • Compiled and reviewed Annual Product Quality Reviews

  • Managed and provided QA oversight to supplier deviations, release-testing and stability OOS investigations for contract-manufactured products

  • Reviewed and approved master production documents, specifications and test methods to assure compliance to product registration requirements

Auditing

  • Hosted regulatory inspections in direct roles as part of the audit hosting team for a manufacturing site and an importer and distributor. Supported audit hosting of numerous client and corporate audits

  • Developed responses to audit observations

  • Conducted gap-analysis on procedures against GMP and corporate Quality System requirements

Validation

  • Reviewed Process Validation study protocols and reports for compliance to Canadian Validation guidances and change control

  • Reviewed Analytical Method Validation and Method Transfers for compliance with ICH guidelines and company procedures

Technical Writing

  • Reporting of deviations and OOS investigations

  • Documenting assessments of impact and risk to product quality

  • Developed SOPs and Work Instructions to support roll out of new Quality Management Systems

  • Drafted Protocols for Inventory Transfers, Sampling, and Transportation Studies

  • Reviewed and edited Protocols and Reports for Process Validation Studies

 

Computer Skills and Electronic Workflows Experience

  • SAP for executing product release and sampling transactions

  • Trackwise: Deviations, CAPA, Change Control workflows

  • SCORE, Livelink systems for document review and approval workflows

Education

  • Pharmaceutical Quality Assurance and Quality Control Diploma, Toronto Institute of Pharmaceutical Technology (TIPT), Toronto ON

  • Honours Bachelor of Science in Chemistry, University of Toronto (U of T), Toronto, ON

Continuing Education, Career Development

  • Certified Pharmaceutical Analyst with training in HPLC Method Development and Validation

  • GMP Regulations and Guidelines

  • GMP & GLP Auditing