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
- 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
- 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