Specialist – Quality Operations

Summary Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines Now as an independently listed company Sandoz aims to increase its strategic focus operate with greater agility set clearer business objectives enhance shareholder returns and strengthen its culture for us the Sandoz associates This is an exciting time in our history and by creating a new and ambitious path it will provide a unique opportunity for us all both professionally and personally Join us as a Founder of our new Sandoz Job Purpose Provide quality services in compliance with cGMP requirements and Sandoz Quality Management System as defined and agreed between GQSI and business partners Manage Quality aspects projects within area of responsibility Your Key Responsibilities Your responsibilities include but not limited to Adherence to the current GxP and compliance requirements of Sandoz perform and deliver Quality Operations in support of product quality compliance and regulatory workflows 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 GQSI Comply with internal functional requirements such as KPI reporting ticket management tools and any other internal procedures and processes Regularly communicate 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 with accuracy and timeliness of deliverables Hold accounts in workflow applications such as SAP GxQEM CONDOR ESOPs TrackWise 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 Comply with internal functional requirements such as KPI reporting ticket management tools and any other internal procedures and processes Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures Assist the department on any other ad-hoc activities requests to meet the business requirements Provide active support during internal and external audits by collecting and presenting the requested process data and reports Learn develop understanding to generate insights through data and digital Support the Master Data Management to the required sites as required Create and review GxP documents including SOPs working procedures trend reports qualification reports and technical investigations as needed Major accountabilities Perform APQR Master plan coordinator role support for creation of draft annual plan and sharing it for approval KQI reporting activities Acting as site owner for maintenance of SharePoint as requested by Business Partner Responsible to update the information on SharePoint trackers review the applicable documents for correctness and archival of necessary documents on SharePoint Provide Administrative support in preparation of Quality Management Review meeting slide deck metrics reporting Maintenance of distribution lists and Active Directory Group Management Perform the role of QA approver for complaints delegated to GQSI Self-Inspection SI Planner role in Applicable Quality Management system Creation of the child record for required target site based on the final SI approved plan for SCQ Author and approver role for metric reporting in QADM tool Develop and maintain process SOPs working procedures and process maps Provide support for GMP External Audits and inspection management activities HA and Self Inspection Audits Maintain Approved supplier list for GxP vendors Ensure the completeness of KQI metrics as per requirement of compliance team Perform QARP CAPA Co-ordinator role in available Quality management system for audit CAPA activities for audits of external suppliers CMOs Preparation of UQAP Unified Quality Audit Program and Audit preparation support QMS Document Maintenance Coordinator Co-ordinating in process of assessment and implementation of Global Sandoz Standards and procedural documents with wide applicability at Sandoz applicable sites Exception Handling Records Perform a role of originator owner Approver in Exception handling system in the available quality management system Gx-QEM Manage different type of deviations Quality Event and its relevant actions CAPAs Generate and analyse predefined and ad-hoc reports from various applications like GxQEM Gx-Quality Event Management GxQANTO Quality Analytics Tool etc and perform follow-up actions if required Follow-up and tracking timely closure of all Deviations Quality Event and actions CAPAs Perform queries in GxQEM as per the SOP Perform Monthly Quarterly Yearly trending and reporting Global Supply Chain GSC Quality support Management of Quality Assurance Agreements and templates for Internal and External service providers Management of Logistics Service Provider LSP certificates Management of Health authority HA licenses Ensure completeness of Key Quality Indicators KQI metrics as per the requirement of compliance team Exception Handling Records Management in Available Quality Management System Support as coordinator for CONDOR Controlled Document Repository System QASH Quality Assurance SharePoint and SC-LCD Supply chain library of classified data What youll bring to the role Essential Requirements Work Experience Experience Min 3 years of experience in Quality Assurance Regulatory or in the manufacturing of pharmaceutical drug substances products medical devices GxP knowledge Basic IT knowledge Experience of working closely with the global stakeholders Languages Fluent in English written and spoken Good communication presentation and interpersonal skills Youll receive Breakdown of benefits received in this role Include flexible working learning and development opportunities as well Why SandozGeneric and Biosimilar medicines are the backbone of the global medicines industry Sandoz a leader in this sector touched the lives of almost 500 million patients last year and while we are proud of this achievement we have an ambition to do more With investments in new development capabilities state-of-the-art production sites new acquisitions and partnerships we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost high-quality medicines sustainably Our momentum and entrepreneurial spirit is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful flexible-hybrid careers where diversity is welcomed and where personal growth is encouraged The future is ours to shape SandozSkills Desired Continued Learning Dealing With Ambiguity Gmp Procedures Qa Quality Assurance Quality Control Qc Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence