Quality Assurance Specialist
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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.
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 !
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1523 comparable Quality roles across 149 biopharma companies.
Salary context
248 of 1523 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1523 comparable roles
+ 47 more countries
Seniority mix
690 of 1523 peers have a known seniority level
Therapeutic area mix
1 of 1523 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.