Quality Assurance Document Analyst
Leda Health Innovations Inc. - Woodbridge, ON

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POSITION SUMMARY

  • The objective of the Quality Assurance Document Analyst is to ensure that the products meet the regulatory standards of the country where the products will be shipped to and the standards of the client
  • Ensure that all products imported by the company meets Health Canada Regulations and implement the quality assurance approval process

ESSENTIAL FUNCTIONS / RESPONSIBILITIES

  • Managing the organizations quality assurance policies and controlling new product development processes
  • Establishing performance standards, procedures, and audit controls in order to meet business requirements
  • Identifying and implementing process improvements to increase efficiency, effectiveness, and quality
  • Providing quality improvement initiatives for all company products and services
  • Performing current regulatory standards for all products and implementing a quality plan to bring the company into regulatory compliance
  • Lead the preparation for Health Canada inspections and audits and provide support to their execution and follow-up. Ensure that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensure timely remediation of any issues related to CAPAs
  • Support new product development
  • Manage all customer complaints and report as per Health Canada rules & regulations
  • Preparing documents for releasing products requiring Health Canada approval

Job Qualifications and Requirements

  • A degree in Chemistry, Pharmaceutical Science or similar
  • Minimum 1 year experience in quality assurance within pharmaceutical industry
  • Familiar with cGMPs, Quality Systems,, manufacturing processes, packaging processes, and current industry practices
  • Familiar with FDA requirements
  • Demonstrated ability to manage metrics, and documentation while introducing continuous improvement initiatives
  • Detailed and organized record keeping skills
  • Solid written and oral communication skills
  • Advanced computer skills and a proficiency in Microsoft Office

SALARY

  • Salary Range: $36,000 - $42,000

Indeed - 18 months ago - save job - block
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