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Quality Analyst Ii Jobs
Company | Teva Pharmaceuticals |
Address | Toronto, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Wellness and Fitness Services,Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-09-24 |
Posted at | 8 months ago |
Who We Are
- 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.
- Investigate Product Complaints and ensure the timely closure of the records in Harmony Track Wise.
- Perform Executed Batch Record Review for Teva affiliate products.
- 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.
- Hazard Recognition and Investigation Skills: Identify, prevent, and proactively correct workplace hazards and conditions. Perform incident/accident investigations, root cause analysis, and establish appropriate corrective actions.
- Review internal procedures and Corporate Standards, perform gap assessment and update SOPs accordingly.
- Draft / revise, negotiate and execute Quality Agreements with manufacturing sites, contract packagers, contract laboratories, etc.
- Review & approve GMP documentation associated with Teva affiliates and 3rd party supplied finished products including release documentation, deviations, validations, change controls, etc.
- Ensure compliant, on-time launches of Teva affiliates product in coordination with internal & external groups.
- Lead / Manage special projects that require collaboration with cross-functional teams and Teva Global Affiliates.
- Role Modeling: Role modelling of EHS practices to prevent the release of materials/energy, reduce EHS impacts, and ensure adherence to EHS regulatory requirements and procedures.
- Good working knowledge of SAP, LIMS, Track wise, Excel and Word.
- Support other Compliance functions and projects as required. Support inspections.
- Thorough understanding of manufacturing, packaging and laboratory operations.
- Perform release of Teva affiliates and 3rd party products to market.
- 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.
- Liaise with Teva affiliates suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues.
- Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner.
- Provide metrics to Teva Global / Track KPIs for overdue deviations, CAPAs, batch release cycle time, etc; Generate / trend monthly and quarterly reports.
- Advance writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
- Associate will face many changing priorities as urgent issues arise and need immediate attention and / or decisions to move forward.
- Excellent verbal and written communication skills.
- Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs, and expectations.
- 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).
- 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.
- Strong analytical, time management and organizational skills.
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