DQA/CQA API-RND

Synzeal Research; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Synzeal Research in Ahmedabad seeks a senior QA leader to drive CQA and DQA for API R&D and commercial manufacturing. You will ensure regulatory readiness, data integrity, and quality management across projects.

Lead QA oversight for First-to-File API development, review critical documents, and mentor QA teams to sustain continuous improvement and strong collaboration with cross-functional partners.

Qualifications

• Experience leading QA for API R&D and commercial manufacturing.
• Mandatory exposure to First-to-File (FTF) API development.
• Hands-on with global regulatory audits and customer inspections.
• Strong knowledge of cGMP, ICH Guidelines, Data Integrity, and Validation.
• Experience in technology transfer, commercialization, and DMF support.
• Excellent leadership, communication, problem-solving, and cross-functional stakeholder management skills.

Responsibilities

• Lead CQA and DQA activities for API R&D and commercial manufacturing.
• Provide QA oversight for First-to-File API development projects from lab scale to commercialization.
• Review and approve SOPs, protocols, reports, specs, batch records, validation docs, and transfer docs.
• Ensure compliance with cGMP, ICH, Data Integrity, 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 validation activities across PV, Cleaning, Method, Equipment, and CSV.
• Collaborate with PR&D, Analytical Development, Manufacturing, QC, Regulatory, Eng, and Supply Chain for timely execution.
• Lead and mentor QA teams to foster continuous improvement and quality culture.

Skills

CQA & DQA leadership

Regulatory audits & inspections

Data Integrity (ALCOA+)

CAPA & Deviation management

DMF support & regulatory submissions

Validation (PV/CSV/QA)

Cross-functional leadership

Technology transfer & DMF support

Job description

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.
• Strong 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.