Novartis is hiring Specialist – Quality Operations
Location: Hyderabad
Summary
This position is responsible to perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
About the Role:
This position is responsible to perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
Key Responsibilities:
• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures. Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
• Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variations) in a predefined format.
• Responsible for collecting stability data and reports for product related evaluations. (e. g. compliance Investigations, divestitures, product transfers, validation. Etc. Support maintenance of APR/PQR schedule.
• Follow-up and tracking of complaint sample availability from Country Organization (CO) to CMO (Contract Manufacturing Organization). Send technical complaints to CMO for investigation. Perform queries in AQWA/Trackwise as per the SOP.
• Perform Quarterly compliant trending and reporting. Perform the role of QA approver for customer complaints delegated to QSC through delegated action.
• Perform a role of change control coordinator or change phase manager in change control management systems like TrackWise and AGILE. Manage different type of change control like product stewardship/Administration Stewardship/Asset Stewardship.
Essential Requirements:
• M. Pharm/ MBA / Engineering/equivalent from a reputed institute.
• 5+ years’ experience in QA/Documentation management, Change management/GXP/QMS
• GxP-knowledge, Broad IT-knowledge
• Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders
• Experience on MAH review, quality compliance management, technical learning & document management system, product release support, stability support services.
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