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Skills Required

manufacturing collaborative development optimization troubleshooting support tracking efficiency communication escalation management leadership scalability compliance audit inspection audits analysis

Work Mode

On-site

Job Type

Full Time

Job Description

Establish and Maintain Relationships with CMO/ CDMO manufacturing organization: Develop and maintain strong, collaborative relationships with CMO/ CDMO manufacturing organization to ensure successful product manufacturing, process development, and scale-up activities Provide technical expertise and guidance to CMOs on process optimization, scale-up, and troubleshooting. Support transfer of new products or processes to external manufacturing sites Monitor Performance Assess the performance of external manufacturing partners, identify opportunities for improvement Ongoing performance tracking for external manufacturing, including quality, cost, delivery, and efficiency. Ensure the alignment of external sites with Teva expectations Communication and Escalation: Serve as the primary point of contact for day-to-day technical and operational issues related to external manufacturing. Escalate concerns to senior management when necessary. Manufacturing Support: Oversee technical aspects of manufacturing processes to ensure they meet product specifications, regulatory standards, and Teva requirements Optimize existing manufacturing processes for efficiency, robustness, and yield Provide technical leadership in scale-up and transfer of new products from development to commercial manufacturing. Process Improvement: Continuously review and improve processes at external manufacturing sites to meet the Teva standards for product quality and operational efficiency Introduce process improvements and ensure effective implementation at external sites Evaluate and implement changes to improve robustness and scalability of manufacturing processes Troubleshooting: Provide technical troubleshooting support for issues that arise at external manufacturing facilities. Lead cross-functional teams to address /resolve issues that impact production timelines Lead investigations into deviations and work with CMOs to implement corrective actions Ensure Compliance: Ensure that all manufacturing activities at external sites are compliant with cGMP, ICH, FDA, EMA, and other applicable regulatory requirements. Audit and Inspection Support: Lead and/or support external manufacturing site audits, inspections, and regulatory submissions, ensuring that CMOs meet all quality standards and regulatory requirements. Deviation and CAPA Management: Lead root cause analysis and corrective actions for manufacturing deviations, non-conformances, and other quality issues at external sites Collaborate with external partners to implement CAPAs effectively Show more Show less

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Teva Pharmaceuticals
Teva Pharmaceuticals
www.tevapharm.com

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

10001 Employees

73 Jobs

    Key People

  • KÃ¥re Schultz

    President and CEO

  • Eli Rosen

    Chief Financial Officer

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