Trainee GBS-GQC Stabl DatAn-GBS-QCSDA G

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

• Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported.
• Provide required stability data to customers for their product compliance files.
  
  

• Prepare Stability Summary Reports within compliance time frame.
• To ensure summary reports are correct and complete as per Apotex procedures.
• Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
• Review Stability data from third party affiliates for compliance.
• Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
• Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
• Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Assistant Manager of any adverse trends detected.
• Works as an effective team member to meet department goals, sharing knowledge with team members.
• Maintain compliance to all health and safety standards, Good Manufacturing Practices, Good Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as Apotex’s Health and Safety policies, and Safe Work Procedures.
• Performs all work in support of our Corporate Values of Courage, Collaboration, Passion and Perseverance; Demonstrates strong and visible support of our values.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.
  
  

• Education
• Master’s Degree in Science / Pharmacy
• Knowledge, Skills and Abilities:
• Have good understanding of pharmaceutical Quality Control systems.
• Demonstrated knowledge of Stability requirements.
• Good interpersonal skills and results oriented team player.
• Able to work with minimum supervision.
• Communicate findings to the Assistant Manager, an escalate any critical issues arising from the Stability summary report.
• Work as part on intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• Good written and verbal communication skills.
• Experience with Microsoft Office applications an added advantage.