PHARMAFull time
Qualification & Validation Expert, Report Issuance
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)ONSITEPOSTED: 10/15/2026
PHARMAFull time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Sanofi is hiring a Qualification & Validation Expert for its Report Issuance team in Hyderabad, part of Global Manufacturing & Supply Services. The role involves writing and reviewing qualification documentation for facilities, utilities and equipment, and keeping that documentation compliant with global Quality requirements.
ROLE DEFINITION & RESPONSIBILITIES
- •Author and technically review facilities, utilities and equipment (FUE) qualification documents, including initial qualification protocols, reports, requalification reports and quality review reports
- •Review protocols and reports for accuracy and completeness of all data
- •Align documentation standards with global Quality requirements and maintain consistency across qualification and validation deliverables
- •Verify data, references and citations in protocols and reports to support regulatory compliance
- •Summarise key findings, provide protocol-aligned interpretation of results and sign reports in Veeva CMS or Kneat
- •Track execution of activities against defined timelines to meet KPI targets and escalate delays as necessary
- •Manage Quality Management System records, address discrepancies and ensure timely closure of documentation
- •Provide training and guidance to team members on compliance topics and best practices
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- More than 5 years' professional experience in qualification
- Bachelor's degree in Engineering, Pharmacy, Chemistry or a related field
PREFERRED QUALIFICATIONS
- •Advanced degrees such as MSc or PhD
- •French or other additional languages
REQUIRED VERIFIED SKILLS
Qualification and validation documentation
Technical writing and review
Data verification and compliance review
Quality systems (Veeva, Kneat)
Quality Management System records handling
GxP and GMP compliance
Microsoft Word, Excel, PowerPoint
Problem-solving
Attention to detail
Organisational skills
Analytical skills
Cross-functional collaboration
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global pharmaceutical company. Its Global Manufacturing & Supply Services function partners with Business and Digital teams to support global Manufacturing & Supply priorities and deliver Global Quality processes from its hubs.
TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology
APPLICATION ADVISORY
Highlight your hands-on qualification experience of more than five years, especially writing and reviewing FUE qualification protocols, requalification reports and quality review reports. Mention any work with Veeva CMS or Kneat for report signing and QMS record closure, since these are named tools in the posting. If you have an advanced degree or French language ability, bring that up as it is listed as a preference.
SPONSORED · TRAINING
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