Quality Operations Specialist Vacancy 2020 @ Novartis
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Job Title: Specialist – Quality Operations
Job Id: 307254BR
Minimum requirements
• M.Pharm/ 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
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 operations in regulatory compliance check and BRR as per the process.
• Generate and analyze predefined and ad-hoc reports in various applications (like AGILE , AQWA, DRAGON etc.) and perform follow-up actions if required.
• Create and review GxP documents like mismatch reports
• Perform and deliver Quality Operations services in support of product quality compliance and
• 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 feedback on support services, report deliverable.
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