QA Associate
Toronto, Canada, Ontario, M1B 2K9
We are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
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.
- Perform other duties as required.
Your experience and qualifications
- University Degree / Science related discipline
- Minimum of 1 (one) year relevant experience in Quality Control, Quality Assurance.
- Knowledge of Health Canada Regulations for Importation.
- 3 (three) + years relevant experience in Quality Control, Quality Assurance or a proven track record within pharmaceuticals is preferred.
- Good working knowledge of SAP, LIMS, QMS, Excel and Word.
- Good knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Importation requirements.
- Thorough understanding of manufacturing, packaging and laboratory operations.
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:
- Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life Insurance
- Employee Assistance Program & Virtual Health Programs
- Retirement Savings Programs
- Employee Stock Purchase Plan (ESPP)
- Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
- Education Assistance Program
- Recognition programs such as Employee Service Awards
- Employee Discounts
- And much more!
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.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
