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Specialist - Quality Operation (GQS-I)

ConfidentialMumbai

24 days ago

Job description

Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows. Adherence to the service KPI s and ensuring the service dashboard, order management framework and time sheet is always kept updated.

Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables. Generate and analyse predefined and ad-hoc reports in various applications (like Trackwise, GxQEM etc.) and perform follow-up actions if required.

Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within Global Quality Solutions.

Align with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Raise service related GxP and non-GxP issues and ensure timely investigation and-compliance with local and global operating procedures. Regularly connect with customers and partners to collect feedback on support services, report deliverables.

Focus on timely completion of all relevant and assigned trainings. Learn & develop understanding to generate insights through data and digital. Ensure responsibility and ownership of the assigned tasks. Comply the accuracy and timeliness of deliverables.

Receive and review the initiated complaints in the QMS tool. Process / Send technical complaints to CMO / Supplier for investigation. Co-ordinate for complaint sample availability, additional information from Country Organization (CO) to CMO (Contract Manufacturing Organization) and vice versa as and when required. Periodic follow up of complaints with supplier for timely investigation.

Perform queries in QMS tools like GxQEM etc. as per the procedures. Reviewing of supplier investigations and completing it in QMS tool for complaints delegated to GQSI. Perform the role of QA approver for complaints delegated to GQSI. Tracking and extension of complaint / actions as per the requirements.

Complete the assigned tasks as per business need. Management of Child records such as Investigation, Communication action etc. as per the requirement. Participate in meetings / discussions between sites and suppliers over supplier complaints as and when required. Perform Quarterly complaint / deviation

Skills Required

quality operations , Regulatory Compliance, Complaint Handling, KPI Reporting

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Quality Specialist • Mumbai

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