Drug Substance / Drug Product - IPQA Executive / Trainee

Location: Puducherry, India

Role: DS / DP IPQA Executive / Trainee

Role & responsibilities for DS - IPQA:

1. In process Quality Assurance activities for Upstream, Downstream and Engineering.
   
2. Line clearance for dispensing raw materials and manufacturing activities.
   
3. Issuance, Distribution, Retrieval and Destruction of SOPs in eDMS.
   
4. Allocation of batch number and issuance of batch documents for the manufacturing activities in eDMS.
   
5. Monitoring the shop floor activities (Manufacturing, cleaning, PM, calibration and breakdown) for Upstream and Downstream process.
   
6. Review and closure of executed BMRs / Qualification documents.
   
7. Issuance and maintenance of WCBs.
   
8. Monthly review of logbooks at shop floor for Upstream, Downstream and Engineering departments.
   
9. APQR preparation and review.
   
10. Completion of assigned training on time in eLMS.
    
11. Review of SOPs, protocol and other technical documents.
    
12. Supporting in commissioning, qualification and validation activities for Upstream, Downstream and Engineering (Process & equipment).
    
13. Supporting in SAP activities for QA function.
    
14. Monitoring and evaluating personnel training records.
    
15. To support the team compile and organize documentation needed for internal and external audits.
    

Role & responsibilities for DP - IPQA:

1. In process Quality Assurance activities for formulation and warehouse departments.
   
2. Line clearance for dispensing raw materials.
   
3. Issuance, Distribution, Retrieval and Destruction of SOPs in eDMS.
   
4. Allocation of batch number and issuance of batch documents for the manufacturing activities in eDMS.
   
5. Monitoring the shop floor activities (Manufacturing, cleaning, PM, calibration and breakdown) for formulation and warehouse departments.
   
6. Review and closure of executed BMRs / Qualification documents.
   
7. Line clearance for manufacturing activities (filling, visual inspection and packing) as applicable.
   
8. Monthly review of logbooks at shop floor for formulation and warehouse departments.
   
9. CPV data collection and APQR preparation and review.
   
10. Completion of assigned training on time in eLMS.
    
11. Review of SOPs, protocol and other technical documents.
    
12. Drug product packing, release and dispatch activities.
    
13. Providing line clearance for sterility testing.
    
14. Supporting in commissioning, qualification and validation activities for formulation and warehouse departments (Process & equipment).
    
15. Supporting in SAP activities for QA function.