Specialist @ Novartis M.Pharm/ MBA / Engineering/equivalent
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Job Purpose:
Provide Quality Service in compliance with cGMP regulatory
requirements and the Novartis Pharma Quality Manual and Policies by
implementing processes, systems and tools that realize the Quality Operations
services across Novartis divisions.
Your responsibilities include, but not limited to
• Perform and deliver Quality Operations services in support
of product quality compliance and regulatory workflows.
• Hold accounts in workflow applications (like SAP, Dragon,
SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables.
• Escalate service related GxP and non-GxP issues and ensure
timely investigation and compliance with local and global operating procedures.
• Ensure compliance to the Novartis internal quality
standards, relevant regulatory requirements, filed product quality standards
and service level agreements.
• Support implementing service quality and process
improvement projects, CAPA management within Quality Service Centers.
• Comply with all internal functional operating procedures
like time tracking, KPI reporting, ticket management tools and other internal
systems and processes. Assist the department on any other ad hoc administrative
activities as per business requirements.
• Regularly communicate with customers and partners to
collect feedbacks on support services, report deliverable.
M.Pharm/ MBA / Engineering/equivalent from a reputed
institute.
• Min 3yr Experience in Quality Assurance, Regulatory or in
the manufacturing of pharmaceutical drug substances/ products/Medical device.
• GxP-knowledge, Broad IT-knowledge
• Fluent in English (written and spoken)
• Good communication, presentation and interpersonal skills.
Experience of working closely with the global stakeholders
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