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Novartis is an equal opportunity employer and welcomes applications from all suitably qualified persons.

Position: Manager – Quality Operations

Location: Hyderabad

Job Description:

Purpose of Position: Use the GxP experience and the well-established knowledge of the Quality Management System and the relevant International Legislation to contribute to the operational business in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies. Support PLS delivery by implementing processes, systems, and tools that realize the Quality Operations services across Novartis divisions. Support the successful implementation of the NBS vision and strategy and the Novartis Quality strategy within the PLS-M&SO organization.

Responsibilities include but are not limited to:

  • Perform Product Quality service operations like technical complaints, technical deviations, product change requests, product release, supplier qualification, product quality review, artworks, GxP documentation, audit support, and application user support within PLS-M&SO.
  • Hold and manage key accounts in workflow applications to ensure appropriate execution of service deliverables.
  • Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA, etc.) and perform follow-up actions if required.

  • Ensure compliance with the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements.
  • Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports, and technical investigations.
  • Lead new service or expansion projects, monitor and report progress and deviations, as appropriate.
  • Regularly communicate with customers and partners to collect feedback on support services, report deliverables, and acquire process knowledge.
  • Support implementing service quality improvement projects within the PLS M&SO organization.
  • Adherence to the service KPIs and ensuring the service dashboard, order management framework, and timesheet is always kept updated.
Qualification: M.Sc – Chemistry/Microbiology/Biotech/M.Pharma

Experience: Minimum 10 Years of Relevant Experience in QA/RA/Production (Pharma)

Salary: Negotiable

Contact Details:

Ms. Supriya Yadav

supriya.yadav_ext@novartis.com

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