Novartis India Specialist-Quality Operations University or
academic degree in Chemistry, Microbiology, Biotechnology, Pharmacy
Job Purpose:
Use the GxP experience and the well-established knowledge of
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 PLS-M&SO organization.
Your responsibilities include but 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 to the Novartis internal quality
standards, relevant regulatory requirements, filed product quality standards
and service level agreements. Create and review GxP documents including trend
reports, qualification reports and technical investigations.
• Regularly communicate with customers and partners to collect
feedbacks on support services, report deliverable and acquire process
knowledge. Support implementing service quality improvement projects within PLS
M&SO organization.
• Adherence to the service KPI’s and ensuring the service
dashboard, order management framework and time sheet is always kept updated.
Minimum requirements
• University or academic degree in Chemistry, Microbiology,
Biotechnology, Pharmacy or equivalent in English
• Experience in chemical/pharmaceutical industry.
• Min. 4-7 yrs Experience in Quality Assurance, Regulatory or
in the manufacturing of pharmaceutical drug substances or products.
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