Department Details
Role Summary
1. Issuance of Batch manufacturing records / BPR's/DR's/APS
2. Issuance of requested additional pages of BMR's/ BPR's/DR's and additional checklists
3. Issuance, control, retrieval and archival of logbooks/Registers, SOP's, Specifications, Layouts/ Drawings , GAM's, Planners and other documents
4. Maintenance of masters, controlled and obsolete of documents
5. Control of documents at QA
6. Archival and storage of documents
7. Providing documents to CFT's as applicable on request and support
8. Participate and support in internal and external audits
9. Co-ordination for self- inspection of B1, B2 and Medical devices
10. Submission of documents as per the request received from regulatory agency or customer.
Key Responsibilities
1. Issuance of Batch manufacturing records / BPR's/DR's/APS.
2.Issuance, control, retrieval and archival of logbooks/Registers, SOP's, Specifications, Layouts/ Drawings , GAM's, Planners.
3.Archival and storage of documents.
4.Co-ordination for self- inspection of B1, B2 and Medical devices
Educational Qualifications
Required Education Qualification: B.Sc
Required Experience: 1 - 3 years
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