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.
- Solid 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