DQA

Chieron Active Ingredients; Hyderabad, Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Chieron Active Ingredients is seeking a role focused on quality oversight for API R&D, process development, scale-up, and tech transfer. The candidate will ensure development activities are scientifically sound, compliant, and inspection-ready, with emphasis on GMP, data integrity and regulatory alignment.

Key responsibilities include reviewing development reports, specifications, analytical methods, and technology-transfer documents, as well as supporting regulatory submissions and customer

Qualifications

• Experience in API R&D quality assurance for development work.
• Solid understanding of GMP, QMS and regulatory expectations.
• Experience with new molecules, process development, scale-up and tech transfer is preferred.

Responsibilities

• Quality oversight of API R&D and process development activities.
• Review and approve development reports, specs, analytical methods and process validation/documents.
• Ensure GMP and data integrity are embedded in development.
• Quality review of new molecule/process development and CDMO projects.
• Support regulatory submissions, audits and inspections.
• Establish and strengthen DQA systems for API R&D.

Skills

API R&D QA

QA for development

Regulatory knowledge

Job description

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.