Officer/ Sr. Officer

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1. CMO Activities

1. Prepare and share the audit agenda as per the approved schedule and conduct vendor audits at Contract Manufacturing Organizations (CMOs).
   
2. Prepare audit reports and communicate findings to the respective vendors.
   
3. Follow up with vendors for submission of compliance reports, review corrective actions, and ensure timely closure of audit observations.
   
4. Review new product and site transfer documents, including technology packs, CMD laboratory testing status, site audit status, and associated documentation for Generic, Branded, and E-Commerce products to support market requirements.
   
5. Coordinate with the PPIC team for pending technology pack documents and ensure timely completion.
   
6. Arrange dispatch of analysis samples to the CMD laboratory and follow up for analytical test results.
   
7. Compile CMO assessment data and prepare presentations for management review.
   
8. Provide necessary support and resources required for handling market complaints related to Zuventus products.
   
9. Review and support preparation of documentation such as MFR, Specifications, BMR/BPR, and other quality documents during technology transfer activities at CMO (Loan License) sites.
   
10. Support CMO (Loan License) sites during regulatory inspections and audits and assist in submission of regulatory compliance documents.
    
11. Track and monitor export batches of Zuventus products for testing at CMD laboratories and ensure availability of Finished Product Certificates of Analysis (FP-COA).
    
12. Review and approve new product artworks for own manufacturing sites and Loan License/Third-Party manufacturing sites.
    

2. Complaint Handling

1. Log, review, and assess product complaints received from customers, PPIC, Marketing, and other stakeholders.
   
2. Acknowledge complaint receipt, verify complaint details, and assess complaint sample status.
   
3. Forward complaints to the concerned manufacturing site and coordinate submission of additional information and complaint samples required for investigation.
   
4. Follow up with manufacturing sites for timely submission of investigation reports, CAPA (Corrective and Preventive Action) plans, and implementation status updates.
   
5. Share investigation reports with the PPIC team and ensure timely complaint closure.
   
6. Track all open complaints and prepare periodic complaint trend analysis and summary reports.
   

3. Corporate Quality Assurance (CQA) Activities

1. Prepare, revise, and implement CQA procedures in line with current regulatory requirements and ensure effective compliance.
   
2. Prepare and revise Batch Manufacturing Records (BMR) and Master Formula Records (MFR) for Loan License sites.
   
3. Coordinate with manufacturing sites to obtain required documentation for export product registrations across different countries.
   
4. Ensure availability and maintenance of vendor qualification documents for regulatory inspections and audits at own and CMO sites.
   
5. Review product technology packs and documentation related to new product development activities in coordination with R&D.
   

4. SAP Activities

1. Create SAP codes for packing materials and finished products.
   
2. Coordinate with PPIC, Commercial, and PMD teams for creation and revision of product codes, packing material BOMs, and finished product BOMs for own manufacturing sites and Loan License CMOs.
   
3. Coordinate with R&D and Export teams for creation and revision of BOMs for export products.
   
4. Ensure all SAP-related activities are completed within approved timelines whenever APIs or finished products are first included in official pharmacopoeias.
   
5. Maintain and upload Label Claim information against Finished Goods (FG) codes in SAP.
   

5. Raw Material Vendor Management

1. Review raw material vendor questionnaires and supporting documents and maintain records in designated repositories.
   
2. Maintain qualified raw material vendor details, source information, and Manufacturer Part Numbers (MPN) in SAP.
   
3. Plan, schedule, and conduct vendor audits for raw material suppliers.
   
4. Prepare audit reports, track compliance actions, and ensure timely closure of audit observations and commitments.