Quality Assurance Specialist

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 innovative 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.