highlisted

Qualification & Validation expert, Report Issuance

Sanofi·Hyderabad

Pay not stated5–9 yrsFull-time

Read from the company's own careers page; you apply on their site.

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About the role

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.

What you'll do

  • Perform comprehensive content and technical writing and reviews to ensure accuracy, completeness, and compliance against approved Templates
  • Review for accuracy and completeness of all data in protocols & reports
  • 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

What you need

  • 5–9 yrs of experience
  • PowerPoint
  • Agile
  • Excel
  • GMP
  • Documentation
  • Technical writing
  • B.Tech or B.E. or M.Sc or PhD

Good to have

  • Chemistry
  • ISO 9001
  • Internal audit
  • Safety management

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