QA Associate

The opportunity

The Quality Assurance Associate I will perform release of imported products (Teva Affiliates and 3rd party) to market and impact assessment with respect to the critical GMP issues. Reviews supplier documentation related to products launches and releases (validation, deviation, change controls, etc.). Conduct investigations related to Commercial Quality deviations, and support importation requirements such as executed batch record reviews and confirmatory testing activities as required. The Quality Assurance Associate will support product quality complaints activities and ensure the timely closure and approval of the records in QMS as required.

How you’ll spend your day

• Provide oversight of activities associated with imported products under Commercial Quality to ensure compliance with GMPs.
• Review & approve GMP documentation associated imported finished products including product launch, release documentation, deviations, validations, change controls, etc.
• Perform release and launch of finished imported products under Commercial Quality.
• Liaise with Teva Affiliates to ensure compliance with GMPs, adherence to Quality agreements and to resolve quality issues.
• Ensure compliant, on-time launches of Teva Affiliates and 3rd party products in coordination with internal & external groups.
• Investigate product complaints and ensure the timely closure and approval of the records in QMS, as required.
• Perform comprehensive and detailed investigations for quality deviations (DR's) related to Teva Affiliates as needed.
• Provide metrics to Teva Global / Track KPIs for overdue deviations, CAPAs, batch release cycle time, etc;
• Generate / trend monthly and quarterly reports.
• Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner.
• Request stability data from the suppliers and perform stability review for all Teva Affiliates and 3rd party products.
• Draft / revise, negotiate and execute Quality Agreements with manufacturing site, contract packagers, contract laboratories, etc.
• Perform impact assessment for Teva Affiliates and 3rd party products towards Critical Incident Notifications / Alerts.
• Perform Executed Batch Record Review for Teva Affiliates products.
• Review internal procedures and Corporate Standards, perform gap assessment and update SOPs accordingly.
• Perform retain sampling activities : conduct the receipt of retain samples, updating SAP / storage of retain samples and destruction of expired retain samples as per procedures.
• Support other compliance functions and projects as required.
• Lead / Manage special projects that require collaboration with cross-functional teams and Teva Global Affiliates.
• Prepare Annual Product Reviews for the market.
• Support activities related to Vendor Master Data.
• Perform other duties as required.

Your experience and qualifications

How We'll Take Care of You

At Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! The typical hiring range for this position is from $70,400-$88,000 annually. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package. Beyond base pay, Teva also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us.

As part of our commitment to well-being, employees may have access to :

More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy and Teva Canada may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing for relevant skills, professional experience, and education, that best match the posted job qualifications. It is important to note that all final decisions in this process are made by a member of the hiring team.