🚀 We’re Hiring: DQA (Development Quality Assurance) Specialist – Dossiers
📍 Experience: 2–8 Years
📌 Employment Type: Full-time
🎓 Qualification: Ph.D. preferred; Postgraduate degree in Life Sciences, Pharmacy, Biotechnology, or related field
⏳ Notice Period: Immediate Joiners Preferred
We are looking for skilled professionals with experience in regulatory dossier management and Development Quality Assurance (DQA). If you have a strong eye for detail and a passion for data integrity and compliance, this role could be a great fit for you.
🔍 Key Responsibilities
- 📑 Review and ensure quality compliance of regulatory dossier data
- 📋 Support preparation and maintenance of Module 3 (CMC), Module 4 (Non-Clinical), and Module 5 (Clinical)
- ✅ Perform end-to-end DQA checks across regulatory documents
- 🔬 Validate source data for accuracy, consistency, and traceability
- ⚖️ Ensure compliance with ICH, WHO, FDA, EMA guidelines
- 🔧 Identify discrepancies and drive corrective/preventive actions
- 🤝 Collaborate with cross-functional teams for dossier compilation
- 🔎 Support audits, inspections, and continuous improvement initiatives
✅ Required Skills
- 💼 Experience in Development QA, Regulatory Affairs, Pharmacovigilance, or Life Sciences
- 📚 Hands-on experience with dossiers and regulatory documentation
- 🧠 Strong understanding of CTD structure (Modules 3, 4, 5)
- 🔐 Knowledge of DQA principles and data integrity frameworks
- 💡 Excellent analytical, communication, and problem-solving skills
📧 How to Apply
👉 Interested candidates can apply or reach out:
resumes@ichor.in
Tags: DQA Jobs, Development Quality Assurance, Regulatory Dossier Jobs, CTD Module 3, CMC, ICH Guidelines, Pharma QA Jobs, Life Sciences Jobs, Regulatory Affairs
