Trainee - Quality Assurance - AQA

Role & responsibilities - Trainee - QA - (AQA)

1. Compiling and reviewing executed analytical data to approve or reject raw materials, intermediates, and finished products.
   
2. Reviewing lab data, logbooks, audit trails, and ensuring SOP adherence for complete, accurate records.
   
3. Support investigations into deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) results.
   
4. Ensuring analytical methods are validated, specifications are adequate, and processes (sampling, testing) comply with cGMP.
   
5. Overseeing lifecycle, calibration, verification, and maintenance of lab equipment.
   
6. Review of QC SOPs / change controls / protocols and other documents.
   
7. Ensure the proper qualification, calibration, and preventive maintenance of all analytical and laboratory equipment.
   
8. Checking labels, preparation, and usage of reagents, chemicals, and standards.
   
9. Conducting regular inspection at the QC lab, verifying cleaning, temperature control, and adherence to procedures.
   
10. Coordinate and participate in internal and external audits to ensure readiness and compliance.
    
11. To provide the line clearance for critical activities at QC laboratory as applicable.
    
12. Completion of assigned training on time in eLMS.
    
13. Preparation and control of QA documents in eDMS.
    
14. Review of SOPs, protocol and other technical documents.
    
15. To support the team compile and organize documentation needed for internal and external audits.