Jobs / India / Sanofi US Services INC
Qualification & Validation expert, Report Issuance
Sanofi US Services INC · 🌍 Hyderabad
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About the role
Job title: Qualification & Validation Expert, Report Issuance • Location: Hyderabad About the job Global Manufacturing & Supply (M&S) Services is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S services. The team members of Global M&S Services (Report Issuance) will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established Global Quality processes from the hubs. The Qualification & Validation Report Issuance team is responsible for authoring facilities, utilities, and equipment (FUE) qualification documents, including initial qualification protocols, reports, and requalification reports, quality review reports. This includes comprehensive activities such as data collection, analysis, drafting, document control, review, approval, sign-off, and preparation for inspections and audits. Main responsibilities: • Perform comprehensive content and technical writing and reviews to ensure accuracy, completeness, and compliance against approved Templates, protocols and guidelines for facilities, utilities, and equipment (FUE) qualification documents, including initial qualification protocols, reports, and requalification reports, quality review reports. • Review for accuracy and completeness of all data in protocols & reports. Align documentation standards with global Quality requirements and maintain consistency across all qualification and validation team deliverables. Verify accuracy of all data, references, and citations included in protocols, reports to ensure regulatory compliance. • Ensure equipment qualification activities comply with Quality regulations and pharmaceutical practices. Summarize key findings and provide clear, protocol-aligned interpretation of results. Perform report signing in Veeva CMS or Kneat. • Perform comprehensive content and technical writing and reviews to ensure accuracy, completeness, and compliance against approved Templates, protocols and guidelines for facilities, utilities, and equipment (FUE) qualification documents, including initial qualification protocols, reports, and requalification reports, quality review reports. • Review for accuracy and completeness of all data in protocols & reports. Align documentation standards with global Quality requirements and maintain consistency across all qualification and validation team deliverables. Verify accuracy of all data, references, and citations included in protocols, reports to ensure regulatory compliance. Ensure equipment qualification activities comply with Quality regulations and pharmaceutical practices. Summarize key findings and provide clear, protocol-aligned interpretation of results. • Translate and adapt protocol, report communications for sites, hubs ensuring clarity and alignment using appropriate Tools. Monitor and track execution of activities against defined timelines to achieve established KPI targets, escalating delays as necessary. Ensure to complete all training in a timely manner. Provide training and guidance to team members on compliance topics and best practices. • Ensures full compliance with GxP principles, regulatory requirements, and Sanofi Quality standards throughout equipment qualification and validation processes. Manage Quality Management System (QMS) records, address discrepancies, and ensure timely closure of all related documentation. Support internal audits and inspections if any by providing required equipment Qualification and validation documentation. • Drive continuous improvement initiatives through standardization, simplification, and digitalization of equipment qualification processes. Perform all tasks in compliance with Good Manufac