Job Title: Quality Assurance Specialist

Location: Goa Site, Verna Industrial Estate, Salcete, Goa, India

About the job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D-driven;, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and cutting-edge pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

Management of Quality Systems

- Compilation, Review & Management of overall Product Quality Reviews system.
- Act as site coordinator for change controls & management of change control system.
- Management of Deviation system.
- Management of Market complaint investigation system.
- Act as QA focal point for OOS/OOT management.
- Management of Training system.
- Oversight on Pest Control system.
- To perform Nitrosamine Assessment & review.
- Management of ICHQ3D requirements.
- Site coordinaator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs)
- Act as focal point for Subcontractors/ Service Providers management.
- Management of overall Validation systems (Process, cleaning, transport & computerized system)
- Management of CAPA System.

Quality Management Systems

- Coordinating for conducting self-inspection as per planner and associated self-inspection activities.
- Review and Approval of GxP documents, batch manufacturing record and batch packing record in electronic-document system.




- Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc.
- Coordination of cGMP training activity including training of the people & review of training module.
- Initiation, implementation, and closure of change controls.
- Initiation of deviation and support in deviation investigation.
- Support in Market Complaint investigation.
- Implementation of assigned CAPAs and support in closure.
- Implementation of assigned Efficiency Reviews (ERs).
- Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned.
- Batch release & response to queries from QP.
- Management of Data integrity aspects.
- Participation and support in SMS initiatives.
- Support for HSE activities.
- Handling of Site Master File (SMF).
- Calibration document review of Engineering/QC/PMTD.
- User access management & review
- Analytical method creation
- Audit trail review
- Document archival/retrieval management.

Validation & Qualifications

- Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities.
- Quality focal point for temperature/ relative humidity mapping activities.
- Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length.
- Quality focal point for utilities & purified water system.




Management of Site Qualification & Validation Master Plan

In-Process Quality Assurance [IPQA]

- Review & Approval of Master Batch Records & executed Batch Records
- Review and Approval of logbooks.
- Line clearance in Production.
- To perform In-process checks in Production.
- Sampling of products during routine production and validation.
- Quality oversight on shopfloor.

HSE

- Adherence to all health safety & environmental aspects as required by company policies and procedures.
- Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
- Conducting daily training in the +QDCI meeting address any unsafe condition.
- Take suggestion from associates to improve the work conditions with great safety and zero risk.
- Periodic review of the implemented procedures and evaluation of the same.
- Train people on safety and their job to ensure zero LTI and IWLT at workplace.

About you

-
Experience: 2 to 5 Years.
- Technical skills: Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance.
- Qualification: B.Pharm / M.Pharm
- Languages: English, Hindi, Konkani, Marathi
- 3 Shift Working

Why choose us?

.

- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale.
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
- Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
- Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.

📌 Quality Assurance Specialist (Verna)
🏢 Sanofi
📍 Verna