ApoPharma, part of the Apotex group of companies, is dedicated to advancing patient care through innovative medicines. The company is a global leader in pharmaceutical research, with a strong focus on the pathological role of iron in human disease and the development of therapies to improve patient outcomes.
They are currently hiring a Stability Scientist to join their Quality team. This role focuses on reviewing and summarizing stability data to ensure that Apotex commercial products continue to meet compliance and shelf-life requirements.
🔑 Job Responsibilities
As a Stability Scientist at ApoPharma, you will:
- Prepare and review Stability Summary Reports within compliance timelines.
- Ensure reports are accurate, complete, and follow Apotex SOPs.
- Provide data for special projects and product evaluations.
- Review stability data from third-party affiliates for compliance.
- Conduct Stability Impact Assessments for out-of-trend results.
- Monitor product stability trends to justify approved shelf life.
- Contribute to Annual Product Quality Reviews (APQR).
- Notify management of adverse stability trends.
- Collaborate with QA, QC, and inter-departmental teams.
- Adhere to GMP, GDP, safety standards, and regulatory requirements.
🎓 Job Requirements
- Education: Master’s Degree in Science / Pharmacy.
- Strong understanding of pharmaceutical Quality Control systems.
- In-depth knowledge of stability requirements in pharmaceuticals.
- Excellent communication (written & verbal) and interpersonal skills.
- Ability to work independently and escalate critical findings.
- Proficiency in Microsoft Office is an added advantage.
🌟 Benefits of Working at ApoPharma
- Inclusive and accessible work culture.
- Professional growth in a global pharmaceutical company.
- Exposure to cutting-edge research in novel medicines.
- Health and safety-driven work environment.