Qualification & Validation expert, Report Issuance
HyderabadFull-time5–9 yrsPosted 5 days ago
Closed
Senior pharma role at Sanofi in Hyderabad. Needs 5+ years and a B.Tech, B.E. or M.Sc.
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
- PowerPoint
- Agile
- Excel
- GMP
- Documentation
- Technical writing
Good to have
- Chemistry
- ISO 9001
- Internal audit
- Safety management