Senior Quality and Compliance Analyst

Senior Analyst - Global Quality & Compliance

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

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.

Job Responsibilities

• 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.

 

Responsabilités inhérentes à l’emploi

Job Requirements

• 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.
  • Experience
  • N / A

Exigences liées au poste

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

Experience Level

Senior Level