Posted:2 months ago| Platform:
Work from Office
Full Time
1. Monitoring shop floor ASD & FD execution activities and ensuring compliance and adherence to quality systems at all levels of development. 2. Review and approval of AMV, AMD, AME & AMT Protocols and Reports. 3. Review & Authorize Specification and standard test procedures for API, Finished product, excipients, consumables and packaging materials. 4. Receipt, numbering and circulation of API DMF. 5. Authorizing creation of item codes/SFG/FG/consumer code requests and related documentation. 6. Review & approval of Formulation Development associated documentation like PDP, PDR, MFR, SDS, QRM, PEEB, PETBs, Stability protocols of all R&D studies. 7. Review and approval of Packaging development documents Viz.; PKDR, MPRetc. 8. Review and approval of all MS&T and Site transfer related documents. 9. Assessment & approval of Impurity Assessment reports like Nitrosamine, Elemental impurities & residual solvents.
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