Quality Assurance Specialist

Sanofi; South Goa District; On-site; INR 500,000 - 900,000; Full time

Job summary

Sanofi Goa Site in Verna is hiring a Quality Assurance Specialist to support IPQA, batch release, and shopfloor governance in a fast-paced manufacturing environment. You will coordinate change controls, CAPAs, and market complaint investigations while ensuring data integrity and GMP compliance across QA activities.

The role requires 2–5 years of relevant QA experience and a B.Pharm or M.Pharm degree, with English and local languages considered an asset.

Qualifications

• Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance.
• 2 to 5 years of relevant experience preferred.
• English, Hindi, Konkani, Marathi language skills advantageous.

Responsibilities

• Manage Quality Systems including Product Quality Review compilation and review.
• Coordinate change controls and change control system management.
• Oversee deviation, market complaints, and OOS/OOT handling.
• Lead training management and GMP documentation control.
• Support CAPA, data integrity, and QMS activities.
• Ensure GMP compliance on shopfloor and during batch release.

Skills

IPQA

Batch Record Review

Shopfloor Quality Governance

Quality Assurance

Education

B.Pharm / M.Pharm

Job description

## Quality Assurance SpecialistBewerben: Verna: Vollzeit: Heute ausgeschrieben: Enddatum: 6. November 2026 (Noch 29 Tage Zeit für Bewerbung): R2873750**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.