Quality Assurance Officer

Daffodil Pharmachem; Ahmedabad District; On-site; INR 450,000 - 650,000; Full time

Job summary

Daffodil Pharmachem in Ahmedabad is seeking a QA professional to oversee QA activities in line with GMP, GDP, and regulatory requirements. You will review and approve BMR/BPR, SOPs, specifications, protocols and reports, and ensure cGMP, WHO-GMP compliance within the quality systems of the company.

The role involves managing deviations, CAPA, change controls and investigations; conducting internal audits and supporting customer/regulatory audits, and coordinating with QC, Production, Engineering

Qualifications

• Strong knowledge of GMP, GDP and Quality Management Systems (QMS).
• Experience in documentation, deviations, CAPA and change control.
• Good understanding of pharmaceutical manufacturing processes.

Responsibilities

• Handle QA activities as per GMP and regulatory requirements.
• Review and approve BMR/BPR, SOPs, specifications, protocols and reports.
• Ensure compliance with cGMP, WHO-GMP and company quality systems.
• Manage deviations, CAPA, change controls and investigations.
• Conduct internal audits and support customer/regulatory audits.
• Monitor documentation and batch release activities.
• Coordinate with QC, Production, Engineering and Warehouse departments.
• Ensure proper implementation of SOPs and quality procedures.

Skills

GMP & GDP

QMS knowledge

Documentation & record-keeping

Regulatory & audit compliance

Communication & analytical skills

Job description

Role & responsibilities

• Handle QA activities as per GMP and regulatory requirements.
• Review and approve BMR/BPR, SOPs, specifications, protocols and reports.
• Ensure compliance with cGMP, WHO-GMP and company quality systems.
• Manage deviations, CAPA, change controls and investigations.
• Conduct internal audits and support customer/regulatory audits.
• Monitor documentation and batch release activities.
• Coordinate with QC, Production, Engineering and Warehouse departments.
• Ensure proper implementation of SOPs and quality procedures.

Preferred candidate profile

• Strong knowledge of GMP, GDP and Quality Management Systems (QMS).
• Experience in documentation, deviations, CAPA and change control.
• Good understanding of pharmaceutical manufacturing processes.
• Good communication, analytical and documentation skills.
• Knowledge of regulatory requirements and audit compliance.