Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Specialist - Quality Operations
Job Description
• 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. 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.
Candidate Profile
• M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
• 5+ years’ experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. 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.
Additional Information
Experience : 5+ years
Qualification : M.Pharm / MBA / Engineering / equivalent
Location : Hyderabad
Industry Type : Pharma
Functional Area : Quality
End Date : 25th July, 2023
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