Teva Praktikant m/w/d Marketing Patient & Consumer 

Germany, Baden-Württemberg, Ulm 

14735513

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 3rd party suppliers to ensure compliance with GMPs. In addition, will review and approve supplier documentation related to product release, validation, deviation, change controls, etc. In addition, perform release of Teva Affiliates and 3rd party products to market and impact assessment with respect to the critical GMP issues. The Quality Assurance Associate will investigate product complaints and ensure the timely closure and approval of the records in Harmony Trackwise as required, and as needed support with on-time launches of Teva Affiliates and 3rd party product in coordination with internal & external groups.

• Provide oversight of activities associated with the manufacture & packaging of bulk & finished products by Teva Affiliates and 3rd party suppliers to ensure compliance with GMPs.
• Review & approve GMP documentation associated with Teva Affiliates and 3rd party supplied bulk & 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 and 3rd party suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues.
• Ensure compliant, on-time launches of Teva Affiliates and 3rd party products in coordination with internal & external groups.
• Investigate product complaints and ensure the timely closure and approval of the records in Harmony Trackwise, as required.
• Perform comprehensive and detailed investigations for quality deviations (DR's) related to Teva Affiliates and 3rd party products 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.
• Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner.
• Request stability data from the suppliers and perform stability review for all Teva Affiliates and 3rd party products.
• Draft/revise, negotiate and execute Quality Agreements with manufacturing site, contract packagers, contract laboratories, etc.
• Perform impact assessment for Teva Affiliates and 3rd party products towards Critical Incident Notifications / Alerts.
• Perform Executed Batch Record Review for Teva Affiliates and 3rd party 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 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.

Perform other duties as required.

• Minimum of 1 (one) year relevant experience in Quality Control, Quality Assurance.
• Knowledge of USP, BP EP, compendia methods as well as ability to read and interpret house methods.
• Preferred: 3 (three) + years relevant experience in Quality Control, Quality Assurance or a proven track record within pharmaceuticals.
• Good working knowledge of SAP, LIMS, Trackwise, Excel and Word.
• Good knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Manufacturing.
• Thorough understanding of manufacturing, packaging
• Advanced 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 evaluate work processes and outcomes.
• Problem solving skills: 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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