Qualification & Validation expert, Report Issuance

Sanofi; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sanofi Hyderabad seeks a Qualification & Validation Expert for Report Issuance to author and review FUE qualification documents. You will ensure accuracy, regulatory compliance, and alignment with global quality standards across protocols and reports.

You will sign off on qualification reports in Veeva/Kneat, monitor timelines, and support internal audits while driving continuous improvement of qualification processes within GMP and HSE guidelines.

Qualifications

• 5+ years’ professional experience in qualification
• Experience in FUE qualification documentation and validation processes
• Familiarity with GMP/GxP regulations and QA practices

Responsibilities

• Author and review FUE qualification documents (protocols, reports, requalification reports) for facilities, utilities, and equipment
• Ensure data accuracy, references, and citations meet regulatory standards
• Sign reports in Veeva CMS or Kneat and ensure timely delivery
• Support audits/inspections with complete qualification documentation
• Maintain alignment with global quality requirements and KPI timelines

Skills

Problem-solving

Attention to detail

Organizational skills

Cross-functional teamwork

Analytical skills

Agile thinker

Education

Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field

Advanced degrees (MSc/PhD) preferred

Tools

Veeva

Kneat

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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 Manufacturing Practice (GMP) and Health, Safety, and Environment (HSE) requirements, following established instructions, procedures, and records. Execute additional duties as assigned by the manager or team lead, as needed, beyond the responsibilities outlined above.

About you

Experience

>5 years’ professional experience in qualification

Soft skills

Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments

Technical skills

Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point

Education

Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field. Advanced degrees (e.g., MSc, PhD) preferred

Languages

Excellent English communication and writing, French or other Languages in addition preferred

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.