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The opportunity
The Quality Assurance Associate will provide support to operations by providing oversight to activities associated with the manufacturing and packaging of bulk and finished products by Teva affiliates and third-party suppliers to ensure compliance with GMPs. Review and approve supplier documentation related to product release, validation, deviation, change controls, etc. Perform release of third-party products to market. Perform impact assessment with respect to the critical GMP issues.
How you’ll spend your day
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