DQA

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:

• Strong 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.