Role:

Responsible for Quality oversight and assurance for API R&D;, process development, scale-up, technology transfer, and CDMO projects, ensuring development activities are scientifically sound, compliant, and inspection-ready.

Key Responsibilities:
Quality oversight of API R&D; and process development activities.
Review/approval of development reports, specifications, analytical methods, process validation/optimization and technology-transfer documents.
Ensure GMP, data integrity, ICH and regulatory expectations are incorporated during development.
Quality review of recent molecule/process development and CDMO projects.
Support regulatory submissions, customer audits and regulatory inspections.
Establish and strengthen DQA systems for API R&D; and development projects.

Preferred Profile:
Robust experience in API R&D; Quality / QA / Quality Assurance for development.
Good understanding of API chemistry, analytical development, QMS, GMP and regulatory requirements.
Experience with current molecules, process development, scale-up and technology transfer is preferred.
Strong communication, scientific review and cross-functional coordination skills.

📌 Dqa Ahmedabad
🏢 Chieron Active Ingredients
📍 Ahmedabad