Cipla is inviting applications for the position of Team Member – Toxicologist – GTI Risk Assessment at its Vikhroli, Mumbai location. This is a full-time, on-site opportunity for professionals with expertise in toxicological risk assessment, genotoxic impurity (GTI) evaluation, nitrosamine risk assessment, and ICH M7 compliance.
With increasing global scrutiny on genotoxic impurities and nitrosamines, this Cipla toxicologist job offers exposure to regulatory-driven risk assessment aligned with ICH, USFDA, EMA, and DCGI guidelines.
🔬 Key Responsibilities – Toxicologist (GTI Risk Assessment)
The selected candidate will be responsible for:
1️⃣ Genotoxicity Hazard Assessments
- Perform Genotoxic Impurity (GTI) risk assessment using published and experimental in-vitro/in-vivo data.
- Apply (Q)SAR tools in line with ICH M7 guidelines.
- Conduct weight-of-evidence evaluations and document scientific justifications.
2️⃣ Nitrosamine Risk Evaluation
- Conduct nitrosamine impurity evaluations.
- Derive acceptable intake limits based on global regulatory guidelines.
- Perform read-across assessments and document scientific rationale.
3️⃣ Toxicological Risk Assessment (TRA)
- Conduct TRA for:
- Pharmaceuticals & excipients
- Intermediates & degradation products
- Cleaning agents & residual solvents
- Elemental impurities & chemicals
- Support regulatory submissions with robust scientific documentation.
4️⃣ Regulatory & Cross-Functional Collaboration
- Ensure compliance with ICH, USFDA, EMA, CFDA, DCGI regulations.
- Interact with CROs and cross-functional teams.
- Support dossier preparation and regulatory risk documentation.
🎓 Qualifications & Experience
Educational Requirements
- Master’s or advanced degree in:
- Toxicology
- Pharmacology
- Zoology
- Veterinary Medicine
- OR Medicinal Chemistry with GTI/QSAR/nitrosamine evaluation experience
Experience
- 2–5 years of experience in:
- Toxicological risk assessment
- Experimental toxicology
- Pharmaceutical, CRO, or biotech industry
Technical Skills
- Strong knowledge of:
- ICH M7 guidelines
- GTI and nitrosamine evaluation
- Regulatory toxicology documentation
- Proficiency in:
- Microsoft Office Suite
- QSAR software tools
- Data mining & citation tools
- SharePoint
📍 Job Location & Operational Details
- Location: Vikhroli, Mumbai
- Mode: Full-time, Work from Office
- Shift: General (8 hours)
- Travel: Rare/Occasional
💼 Salary & Benefits (Estimated)
Based on industry benchmarks for toxicologist roles in Mumbai:
- Estimated Salary Range: ₹8,00,000 – ₹14,00,000 per annum (CTC)
- Exposure to global regulatory toxicology standards
- Opportunity to work on high-impact GTI and nitrosamine projects
- Career growth in regulatory toxicology and risk assessment
🚀 Why This Cipla Toxicologist Job Is Important
With evolving regulatory expectations around genotoxic impurities (GTIs) and nitrosamine contamination, pharmaceutical companies require scientifically sound toxicological risk assessments to maintain compliance and ensure patient safety.
This role directly contributes to:
- Regulatory submission quality
- Global market compliance
- Risk mitigation in pharmaceutical manufacturing
Professionals seeking careers in pharmaceutical toxicology, regulatory toxicology, GTI evaluation, QSAR toxicology, or nitrosamine risk assessment jobs in Mumbai will find this opportunity highly relevant.
📩 How to Apply
