Quality Associate II

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.

Our Team, Your Impact

QA Associate

We are looking for a Quality Assurance Associate II to join our team. In this role, you will be responsible for reviewing and approving changes in SAP MDG related to GXP fields, creating and approving inspection plans in SAP and providing support as needed, reviewing and approving stability reports, conducting corporate standard gap assessments, evaluating and closing change controls, as well as auditing executed batch records. You will support new product launches and the release of imported products to the Canadian market, including assessing the impact of critical GMP-related issues. The role also involves reviewing supplier documentation related to product launches, product releases, validation activities, deviations, and change controls.

As a Quality Assurance Associate II, you will lead and support investigations related to deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, while ensuring compliance with regulatory and quality requirements. Additionally, you will investigate product complaints and ensure the timely review, closure, and approval of records within the Quality Management System (QMS), collaborating closely with both internal and external stakeholders to drive quality and compliance across operations.

How You’ll Spend Your Day

• Review and approve changes in SAP MDG related to GxP field, create and approve inspection plans in SAP and provide support as needed.
• Provide quality oversight for activities related to imported products.
• Review and approve GMP documentation for products supplied by Teva affiliates and third-party manufacturers, including release documentation, deviations, validations, and change controls.
• Perform product release activities for Teva affiliate and third-party products destined for the Canadian market.
• Collaborate with Teva affiliates and Local-to-Local (L2L) third-party suppliers to ensure GMP compliance, adherence to Quality Agreements, and timely resolution of quality issues.
• Support the compliant and timely launch of products manufactured by Teva affiliates and third-party partners through effective coordination with internal and external stakeholders.
• Investigate, review, and approve product complaints, ensuring timely closure of records within the Quality Management System (QMS).
• Conduct thorough investigations of quality deviations and perform impact assessments related to Critical Incident Notifications and Alerts affecting imported products.
• Monitor and report quality metrics and KPIs, including deviations, CAPAs, and batch release cycle times; prepare monthly and quarterly trend reports and drive timely completion of quality actions.
• Perform executed batch record reviews for products supplied from non-MRA countries
• Prepare, review, and approve Annual Product Reviews (APRs) for imported and L2L manufactured or packaged products.
• Support Vendor Master Data activities and ensure accuracy of quality-related information.
• Review internal procedures and corporate standards, conduct gap assessments, and update SOPs to ensure ongoing compliance.
• Oversee retain sample management activities, including receipt, storage, SAP updates, and destruction of expired samples in accordance with established procedures.
• Support compliance initiatives, quality projects, regulatory inspections, and audit activities as required.
• Lead and manage special projects involving cross-functional teams and Teva Global affiliates.
• Perform other related duties as assigned.
  
  

Your Skills And Experience

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Microbiology, Life Sciences, or a related scientific discipline from a Canadian university, or an equivalent degree recognized by a Canadian university or accredited Canadian credentialing body.
• 3+ years of relevant experience in the pharmaceutical industry.
• Experience in Quality Assurance, Quality Control, or other GMP-regulated environments.
• Knowledge of USP, BP, and EP compendial methods and the ability to interpret and apply analytical testing methods.
• Experience conducting analytical method evaluations and investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Strong understanding of Good Manufacturing Practices (GMP), current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Working knowledge of quality systems including deviations, CAPAs, change controls, product complaints, and batch record review processes.
• Proficiency with Oracle, LIMS, QMS, SAP MDG, Microsoft Excel, and Microsoft Word.
• Thorough understanding of pharmaceutical manufacturing, packaging, laboratory, and testing operations.
• Strong analytical, investigation, problem-solving, and organizational skills.
• Excellent written and verbal communication skills with the ability to collaborate effectively with internal and external stakeholders.
  
  

Also Good to Have

Salary Range

How We’ll Take Care Of You

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.  When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. 

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.