Role & responsibilities

- Lead CQA and DQA activities for API R&D; and commercial manufacturing.

- Provide QA oversight for First-to-File (FTF) API development projects from laboratory scale to commercialization.

- Review and approve SOPs, protocols, reports, specifications, batch records, validation documents, and technology transfer documentation.

- Ensure compliance with cGMP, ICH guidelines, Data Integrity (ALCOA+), and Quality Management Systems.

- Manage Quality Systems including Deviations, CAPA, Change Control, OOS/OOT, Risk Assessment, and Vendor Qualification.

- Drive inspection readiness and lead customer and regulatory audits

- Support DMF-related quality documentation and regulatory submissions.

- Ensure effective implementation of Process Validation, Cleaning Validation, Method Validation, Equipment Qualification, and Computer System Validation (CSV).

- Collaborate with PR&D;, Analytical Development, Manufacturing, QC, Regulatory Affairs, Engineering,



and Supply Chain teams to ensure timely execution of development projects.

- Lead and mentor QA teams while driving continuous improvement and quality culture across the organization.

Preferred candidate profile

- 1520 years of experience in the API pharmaceutical industry.

- Mandatory exposure to First-to-File (FTF) or complex generic API development.

- Robust experience in Development QA (DQA) and Corporate QA (CQA).

- Hands-on experience with global regulatory audits and customer inspections.

- Sound knowledge of cGMP, ICH Guidelines, Data Integrity, Quality Risk Management, and Validation.

- Experience in technology transfer, commercialization, and DMF support.

- Excellent leadership, communication, problem-solving, and cross-functional stakeholder management skills.

Interested Candidates can mail CV on [email protected] or contact (phone hidden)

📌 DQA/CQA API-RND (Ahmedabad)
🏢 SynZeal Research
📍 Ahmedabad