Assistant Manager - DS IPQA / DP IPQA - Quality Assurance

Location: Puducherry

Department: Quality Assurance

Role & responsibilities - AM - Drug Product IPQA

1. Handling of Quality Management Systems (QMS).
   
2. Preparation and review of quality assurance procedure for new and existing activities.
   
3. Preparation, coordination and execution of vendor audit and vendor qualification.
   
4. Preparation, coordination and execution of internal audit.
   
5. Preparation, coordination and execution of external audit.
   
6. Manage site risks for compliance to cGMP requirements.
   
7. Review of process validation protocol and reports related to drug product manufacturing process.
   
8. Follow up with relevant department for conformance of audit observations / non-conformance, assess adequacy of CAPA and closure.
   
9. Review of drug product manufacturing related equipment qualification protocol and reports.
   
10. Review of annual product quality review report for drug products.
    
11. Preparation and review of Quality Management Review report.
    
12. Review of user requirement specification for new equipment & instrument procurement.
    
13. Review and approval of Batch Manufacturing Record and Batch Packing Record of drug product.
    
14. Review of packing material artwork.
    
15. Periodic revision of SOP and implementation of new SOP.
    

Role & responsibilities - AM - Drug Substance IPQA

1. Handling of Quality Management Systems (QMS).
   
2. Preparation and review of quality assurance procedure for new and existing activities.
   
3. Preparation, coordination and execution of vendor audit and vendor qualification.
   
4. Preparation, coordination and execution of internal audit.
   
5. Preparation, coordination and execution of external audit.
   
6. Manage site risks for compliance to cGMP requirements.
   
7. Review of process validation protocol and reports related to drug substance manufacturing process.
   
8. Follow up with relevant department for conformance of audit observations / non-conformance, assess adequacy of CAPA and closure.
   
9. Review of drug substance manufacturing related equipment qualification protocol and reports.
   
10. Review of annual product quality review report for drug substance.
    
11. Preparation and review of Quality Management Review report.
    
12. Review of user requirement specification for new equipment & Instrument procurement.
    
13. Review and approval of Batch Manufacturing Record and Batch Packing Record of drug substance.
    
14. Review of packing material artwork.
    
15. Periodic revision of SOP and implementation of new SOP.