Teva Quality Assurance Associate - month contract 

Canada, Ontario, Toronto 

821099012

• Provide oversight of activities associated with the manufacture & packaging finished products by Teva affiliates and interact with EMSO QA who manages 3rd party suppliers to ensure compliance with GMPs.
• Review & approve GMP documentation associated with Teva affiliates and 3rd party supplied finished products including release documentation, deviations, validations, change controls, etc.
• Perform release of Teva affiliates and 3rd party products to market.
• Liaise with Teva affiliates suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues.
• Ensure compliant, on-time launches of Teva affiliates product in coordination with internal & external groups.
• Investigate Product Complaints and ensure the timely closure of the records in Harmony TrackWise.
• Perform comprehensive and detailed investigations for quality deviations (DR’s) in a timely manner.
• Perform impact assessment for third party products towards Critical Incident Notification / Alerts.
• 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.
• Draft / revise, negotiate and execute Quality Agreements with manufacturing sites, contract packagers, contract laboratories, etc.
• Perform Executed Batch Record Review for Teva affiliate 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 of 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.
• Other duties as assigned

• One (1) to two (2) year’s relevant experience in Quality Control, Quality Assurance or Operations. Knowledge of USP, BP, EP compendia methods as well as ability to read and interpret house methods.
• Three (3) years relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceutical industry preferred
• 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.
• Good working knowledge of SAP, LIMS, Trackwise, Excel and Word.
• Good working knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Manufacturing.
• Thorough understanding of manufacturing, packaging and laboratory operations.
• Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
• Highly organizational skills used to set and manage changing priorities, handle multiple tasks in a timely manner, and ability to consistently evaluate work processes and outcomes.
• Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions
• Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs, and expectations.
• Strong analytical skills.
• Excellent verbal and written communication skills.

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