Quality Associate

Location: Toronto, ON

Job Summary

The Quality Associate will participate in quality assurance and quality control activities. The role will ensure that Teligent Canada drug products are in compliance with the Regulatory filling and GMP requirements of Health Canada. Responsible for aiding with Quality Assurance and Quality Control as well as Quality Compliance functions in support of the import and distribution of sterile and topical drug products. The individual will assist in establishment licensing, document control, batch review, product release, CMO and vendor surveillance/oversite, GMP audits, complaints, CAPAs and compliance, including SOPs, Validation/Qualification documentation and Change Control, and post-market vigilance activities for the Canadian site.

Essential Responsibilities

  • Review of compendia for monograph updates and revision to specifications where necessary
  • Monitor Health Canada labelling database for PM updates
  • Coordination of label changes
  • Assist in retrieving and compiling GMP information to maintain the DEL
  • Maintenance and management of quality system records, including: SOPs, change controls, batch records, product labelling, product specifications, GMP certificates, quality agreements, annual product reports, product release records
  • Assist in the handling of complaints
  • Assist in the management of the stability program:
  • Update stability records with current stability results
  • Stability project management: Draft lot specific testing protocols, obtain quotes, perform stability trending
  • Draft annual product quality reports
  • Other duties as requested

Core Competencies

  • BSc in Chemistry, Pharmacy or other Life Science
  • Thorough and demonstrated knowledge of TPD, ICH Guidelines, GMPs, regulations and other relevant policies
  • Strong written and verbal communication skills
  • Excellent organization, time management and prioritization skills
  • Works well under pressure in a team-based environment
  • Meticulous and detail-oriented with strong work ethic
  • Sound problem solving and decision-making abilities
  • Works independently and accomplishes tasks without supervision
  • Proficient user of Microsoft Office products

Physical Demands

  • While performing the duties of this job, the employee is regularly required to communicate orally and in writing. The employee frequently is required to stand.  The employee must occasionally lift and/or move up to 40 pounds. The employee is frequently required to visually inspect product and must have the ability to see clearly at close vision (20 inches or less) and at a distance of 20 feet or more.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Accommodations will be made to enable individuals with disabilities to perform the essential functions, to the point of undue hardship, in accordance with applicable laws.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs