Specialist Operations GQSI

Posted 4 Days Ago
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Sandoz, CA, USA
In-Office
Mid level
Biotech • Pharmaceutical
The Role
Manage quality operations and compliance within Sandoz, ensuring adherence to regulatory requirements and implementing quality improvement projects. Communicate with partners for feedback, and generate reports in various applications.
Summary Generated by Built In

Job Description Summary

Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Provide quality services in compliance with cGMP requirements and Sandoz Quality Management System as defined and agreed between GQSI and business partners. Manage Quality aspects & projects within area of responsibility.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!

Job Description

Major accountabilities: 

  • Adherence to the current GxP and compliance requirements of Sandoz, perform and deliver Quality Operations in support of product quality compliance and regulatory workflows.

  • Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.

  • Support implementing service quality and process improvement projects, CAPA management within GQSI.

  • Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes.

  • Regularly communicate with customers and partners to collect feedback on support services, report deliverables. Focus on timely completion of all relevant and assigned trainings.

  • Learn & develop understanding to generate insights through data and digital.

  • Ensure responsibility and ownership of the assigned tasks. Comply with accuracy and timeliness of deliverables.

  • Hold accounts in workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise etc.) to ensure appropriate execution of service deliverables.

  • Generate and analyse predefined and ad-hoc reports in various applications (like Trackwise, GxQEM, etc.) and perform follow-up actions, if required.

  • Generic and Biosimilar medicines are the backbone of the global medicines industry.

Why Sandoz?

Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape!

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence
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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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