QA AQA Executive – Injectables

KeyBiz Dashboards Pvt Ltd; Hyderabad; On-site; INR 400,000 - 600,000; Full time

Job summary

A quality assurance company in Hyderabad is seeking a professional with a minimum of 2 years of experience in quality compliance and analytical activities. Responsibilities include reviewing and approving analytical documents, ensuring compliance with GMP and GLP, and participating in internal audits and inspections. The role involves coordination with various departments to maintain quality standards and document control. Ideal candidates should have a strong background in QC lab activities and instrument calibration.

Qualifications

• Minimum 2 years of experience in a relevant sector.

Responsibilities

• Review and approve analytical documents such as STPs, specifications, and reports.
• Ensure compliance of QC laboratory activities with GMP, GLP, and data integrity principles.
• Review analytical data, test results, and certificates of analysis (COA).
• Handle OOS, OOT, deviations, and CAPA related to QC/analytical activities.
• Audit laboratory records, logbooks, and instrument usage.
• Ensure calibration and qualification status of analytical instruments.
• Support method validation, transfer, and verification activities.
• Participate in internal audits and regulatory inspections (USFDA, WHO, EU GMP).
• Ensure proper documentation and control of records as per GDP practices.
• Coordinate with QC, Production, and other departments for quality compliance.

Job description

Responsibilities

• Review and approve analytical documents such as STPs, specifications, and reports.
• Ensure compliance of QC laboratory activities with GMP, GLP, and data integrity principles.
• Review analytical data, test results, and certificates of analysis (COA).
• Handle OOS, OOT, deviations, and CAPA related to QC/analytical activities.
• Audit laboratory records, logbooks, and instrument usage.
• Ensure calibration and qualification status of analytical instruments.
• Support method validation, transfer, and verification activities.
• Participate in internal audits and regulatory inspections (USFDA, WHO, EU GMP).
• Ensure proper documentation and control of records as per GDP practices.
• Coordinate with QC, Production, and other departments for quality compliance.

Qualifications

Minimum 2 years of experience in a relevant sector.