Quaility Intern

Location: Toronto, ON

Essential Responsibilities & Duties:

 The key responsibilities and duties the for which the Quality Intern will be responsible include, but are not limited to:

  • Document control: prepare change controls, participate in reviews of SOPs, maintain electronic and hard copy GMP records according to company policies and practices
  • Stability program: track stability lots and timepoints and enter stability data into Teligent Stability program
  • Labelling and Product Monographs: prepare and review mock labelling & PMs for new products; coordinate changes with graphic artist. Weekly review of Health Canada Product Monograph website for CRP labelling changes.
  • Draft Annual Product Quality Reports
  • Assist in complaint handling; tracking internal database and following up with customers.
  • Review of compendia for monograph updates and revision to specifications where necessary
  • Organization and tracking of all quality agreements and product labelling; posting/cataloguing these items on company Sharepoint
  • Updating supplier GMP document library on Sharepoint; tracking expiry dates on DEL; establishing a database of suppliers.
  • Other duties as requested

Qualifications:

  • 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/Factors:

  • While performing the duties of this job, the employee is regularly required to communicate orally and in writing.

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

Apply/Appliquer