Specialist - Quality Operation (GQS-I)

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

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 Purpose:

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.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows. Adherence to the service KPI s and ensuring the service dashboard, order management framework and time sheet is always kept updated.
• Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, 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.
• 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 Global Quality Solutions.
• Align with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Raise service related GxP and non-GxP issues and ensure timely investigation and-compliance with local and global operating procedures. Regularly connect 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 the accuracy and timeliness of deliverables.
• Receive and review the initiated complaints in the QMS tool. Process / Send technical complaints to CMO / Supplier for investigation. Co-ordinate for complaint sample availability, additional information from Country Organization (CO) to CMO (Contract Manufacturing Organization) and vice versa as and when required. Periodic follow up of complaints with supplier for timely investigation.
• Perform queries in QMS tools like GxQEM etc. as per the procedures. Reviewing of supplier investigations and completing it in QMS tool for complaints delegated to GQSI. Perform the role of QA approver for complaints delegated to GQSI. Tracking and extension of complaint / actions as per the requirements.
• Complete the assigned tasks as per business need. Management of Child records such as Investigation, Communication action etc. as per the requirement. Participate in meetings / discussions between sites and suppliers over supplier complaints as and when required. Perform Quarterly complaint/ deviation

What you ll bring to the role:

Minimum Requirements:

Education: Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute.

Languages:

Fluent in English (written and spoken)
Good communication, presentation, and interpersonal skills

Experience:
Minimum 5 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
GxP knowledge, Basic IT knowledge
Experience of working closely with the global stakeholders

Why Sandoz

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

#Sandoz

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence