Assistant Manager / Deputy Manager- Analytical QA

FDC; South Goa District; On-site; INR 600,000 - 900,000; Full time

Job summary

FDC Goa is looking for a QA professional to ensure GLP, GMP, data integrity, and regulatory compliance across laboratory operations. The role includes GLP rounds, documentation verification, analytical review, SOPs, stability activities, and regulatory oversight.

Responsibilities also cover OOS/OOT investigations, trend analysis, audits, training coordination, and ensuring timely closure of quality events in line with cGMP guidelines.

Qualifications

Responsibilities

• Ensure compliance with GLP, GMP, Data Integrity, and regulatory requirements.
• Conduct laboratory GLP rounds and verify documentation, environmental monitoring, instrument usage logs, and status labeling.
• Review analytical reports, chromatograms, calibration records, working standards, and stability documentation.
• Review and prepare QA SOPs and ensure effective implementation.
• Handle stability activities including protocol review, sample pull-out verification, testing schedules, and stability reports.
• Review raw material and packaging material analytical documentation.
• Handle OOS, OOT, Incidents, Deviations, CAPA, and Market Complaint investigations.
• Perform trend analysis and ensure timely closure of investigations.
• Conduct spot audits and ensure compliance with quality systems.
• Review audit trails and ensure data integrity compliance.
• Coordinate internal training programs and maintain training records.
• Ensure compliance with cGMP, GLP, and applicable regulatory guidelines.

Job description

Role & responsibilities

• Ensure compliance with GLP, GMP, Data Integrity, and regulatory requirements.
• Conduct laboratory GLP rounds and verify documentation, environmental monitoring, instrument usage logs, and status labeling.
• Review analytical reports, chromatograms, calibration records, working standards, and stability documentation.
• Review and prepare QA SOPs and ensure effective implementation.
• Handle stability activities including protocol review, sample pull-out verification, testing schedules, and stability reports.
• Review raw material and packaging material analytical documentation.
• Handle OOS, OOT, Incidents, Deviations, CAPA, and Market Complaint investigations.
• Perform trend analysis and ensure timely closure of investigations.
• Conduct spot audits and ensure compliance with quality systems.
• Review audit trails and ensure data integrity compliance.
• Coordinate internal training programs and maintain training records.
• Ensure compliance with cGMP, GLP, and applicable regulatory guidelines.