Teva QA Associate II 

Canada, Ontario, Toronto 

18788045

The QA Associate II supports change control management, review, and approval for Commercial quality related activities. This individual is responsible for processing and managing controlled documents that are under the scope of Commercial quality. The QA Associate II performs product launches and releases 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 product launches and releases, validations, deviations, change controls, etc. The QA Associate II also conducts investigations related to deviations, OOS and OOT, and supports drug establishment licensing management, as required. The QA Associate II investigates Product Complaints and ensures the timely closure and approval of the records in QMS as required, and as needed to support with on-time launches of 3rd party product in coordination with internal and external groups. In addition, the QA Associate II supports with establishing systems and processes for Commercial Quality Canada to align with IM Commercial Quality.

• Manages change control processes, reviews, and approves, for Commercial Quality related activities.
• Responsible for processing and managing controlled documents that are under the scope of Commercial Quality.
• Provides oversight of activities associated with imported products from Teva affiliates and 3rd Party and interacts with EMSO QA who manages 3rd party suppliers to ensure compliance with GMPs.
• Reviews and approves GMP documentation associated with Teva affiliates and 3rd Party supplied finished products including release documentation, deviations, validations, change records, etc.
• Supports completion of stability report updates for products imported from Teva affiliates.
• As required, supports with the drug establishment licensing management.
• Performs release of Teva affiliates and 3rd Party products to Canadian market.
• Liaises with Teva affiliates to ensure compliance with GMPs, adherence to Quality agreements and resolve quality issues.
• Ensures compliant, on-time launches of Teva affiliates and 3rd Party manufactured products in coordination with internal and external groups.
• Investigates, reviews and/or approves product complaints and ensures the timely closure of records in Harmony TrackWise.
• Performs comprehensive and detailed investigations for quality deviations (DRs) in a timely manner. Performs impact assessment for imported products towards Critical Incident Notification / Alerts.
• Performs Executed Batch Record Review for Teva affiliate products.
• Reviews internal procedures and Corporate Standards, performs gap assessments and updates SOPs accordingly.
• Supports with establishing systems and processes for Commercial Quality Canada to align with IM Commercial Quality.
• Supports other Compliance functions and projects as required.
• Supports inspections.
• Leads / manages special projects that require collaboration with cross-function teams and Teva Global Affiliates.
• Other related duties as required.

• Holds a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
• Three (3) + years of relevant experience in Change Control, Documentation, Quality Control and/or Quality Assurance. Knowledge of Health Canada Regulation related to importation requirements. Experience in Word, Excel, QMS
• Preferred: Five (5) years of relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceutical industry
• Good working knowledge of SAP, QMS, Excel and Word. Must be proficient in MS word.
• Good knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Importation.
• Thorough understanding of manufacturing, packaging and laboratory operations.
• Advance writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
• Planning/Organizational skills: Highly organizational skills used to set and manage priorities, handle multiple tasks in a timely manner, and ability to consistently evaluated work processes and outcomes
• Problem solving: Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions. Identifies and solves problems by gathering and applying information from a variety of sources. Must demonstrate ability to recognize critical situations and respond appropriately. Analyzes relationships among several parts of a problem or situation. Ability to anticipate obstacles and think of next steps. Recognizes multiple casual links: several causes of events, several consequences of actions, or multiple part chain of events. (A leads to B leads to C).
• Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs and expectations.
• Strong analytical, time management and organizational skills.
• Excellent verbal and written communication skills.

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