Apotex Inc. is a leading Canadian-based global pharmaceutical company dedicated to producing high-quality, affordable medicines for patients worldwide. With a workforce of over 7,200 employees, Apotex operates in manufacturing, R&D, and commercial sectors, ensuring its medicines reach patients in more than 75 countries. The company focuses on generic, biosimilar, and specialty pharmaceuticals, leveraging vertical integration to enhance accessibility and affordability.
Job Description: Trainee, Quality Stability Data Analysis
Job Summary
As a Trainee, Quality Stability Data Analyst at Apotex, you will be responsible for summarizing and reviewing stability data to ensure that the shelf life of Apotex’s commercial products is scientifically supported. You will also provide necessary stability data to customers for compliance purposes.
Key Responsibilities
- Prepare Stability Summary Reports within the required compliance timeframe.
- Ensure accuracy and completeness of summary reports as per Apotex procedures.
- Generate stability reports for special projects and product evaluations requested by internal/external stakeholders.
- Review third-party stability data for compliance.
- Conduct Stability Impact Assessments for out-of-trend results in drug products.
- Monitor stability data trends to ensure approved shelf life remains justified.
- Contribute to Annual Product Quality Review (APQR) by providing stability review packages.
- Collaborate with teams to meet departmental goals while adhering to GMP, GDP, and safety regulations.
- Ensure compliance with Apotex’s Health & Safety policies and regulatory standards.
- Support company values: Courage, Collaboration, Passion, and Perseverance.
Job Requirements
Education:
- Master’s Degree in Science / Pharmacy or related field.
Skills & Competencies:
- Strong understanding of pharmaceutical Quality Control systems.
- Knowledge of stability study requirements (ICH guidelines).
- Excellent analytical and interpersonal skills.
- Ability to work independently with minimal supervision.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
Preferred Experience:
- Prior exposure to stability data analysis in the pharmaceutical industry is a plus.
Why Join Apotex?
- Work with a globally recognized pharmaceutical leader.
- Opportunity to contribute to life-saving medicines.
- Inclusive and supportive work environment.
- Career growth in GMP, regulatory compliance, and quality assurance.
