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 new 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 new 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