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 transparent, protocol-aligned interpretation of results. Perform report signing in Veeva CMS or Kneat.
• Perform comprehensive content and technical writing and reviews to ensure accuracy, compl

📌 Qualification & Validation expert, Report Issuance (Hyderabad)
🏢 Sanofi
📍 Hyderabad