Executive or Senior Officer - APQR and CPV or AQA

Drlogy; Alwar; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Drlogy is seeking an experienced Executive or Senior Officer - APQR and CPV or AQA to enhance quality assurance within pharmaceutical manufacturing. You will manage Annual Product Quality Reviews, support regulatory compliance, and lead continuous quality improvement initiatives.

Ideal candidates have a strong background in quality trend analysis and process monitoring, ensuring adherence to GMP standards through effective coordination with QA, QC, and production teams.

Responsibilities

• Prepare and review APQR and CPV reports accurately.
• Analyze process performance and product quality trends regularly.
• Ensure compliance with GMP and pharmaceutical quality standards.
• Coordinate with QA, QC, production, and regulatory teams effectively.
• Monitor process capability and product quality performance metrics.
• Maintain APQR, CPV, and AQA documentation systematically.
• Investigate quality trends and support corrective action implementation.
• Participate in audits and regulatory inspection activities.
• Support risk assessment and quality improvement initiatives.
• Ensure timely completion of annual product quality review activities.

Skills

Quality trend analysis

Process monitoring

Documentation management

Regulatory compliance

Continuous quality improvement

Job description

Executive or Senior Officer - APQR and CPV or AQA

Experienced Executive / Senior Officer - APQR & CPV / AQA responsible for managing Annual Product Quality Review (APQR), Continued Process Verification (CPV), and analytical quality assurance activities within pharmaceutical manufacturing environments. Skilled in quality trend analysis, process monitoring, documentation management, and compliance reporting. Adept at supporting regulatory compliance and continuous quality improvement initiatives.

Responsibilities

• Prepare and review APQR and CPV reports accurately.
• Analyze process performance and product quality trends regularly.
• Ensure compliance with GMP and pharmaceutical quality standards.
• Coordinate with QA, QC, production, and regulatory teams effectively.
• Monitor process capability and product quality performance metrics.
• Maintain APQR, CPV, and AQA documentation systematically.
• Investigate quality trends and support corrective action implementation.
• Participate in audits and regulatory inspection activities.
• Support risk assessment and quality improvement initiatives.
• Ensure timely completion of annual product quality review activities.
• Monitor deviations, OOS trends, and process variability data.
• Prepare quality reports and management review summaries regularly.
• Conduct data analysis for process verification and quality monitoring.
• Support implementation of CAPA and change control procedures.
• Contribute to continuous improvement and compliance excellence initiatives.