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As a member of a leading Indian pharma company, you will have the opportunity to see your ideas come to light, rub shoulders with the best of talent, work in a professional environment and see your career soar at Zydus Cadila.
Position: Asst Manager/Dy Manager – Manufacturing Investigator
Location: Moraiya, Ahmedabad, Gujarat, India
1. Shall be responsible for handling Quality events like out of specification and Out of trend cases for Moraiya manufacturing facility
2. Shall be responsible for the execution of Part B (Process investigation pertaining to all applicable manufacturing unit operations) at Zydus dosage form manufacturing facilities.
3. Shall perform a thorough review of Part A’s analytical investigation report to understand the nature of the failure.
4. Shall perform Root cause analysis for OOSs/OOTs observed for solid and other dosage forms.
5. Shall document all applicable raw data, metadata as a part of an investigation to support root cause analysis.
6. Shall review Batch records, packing records, analytical data, stability data, process development reports, engineering batch data, ongoing process verification reports, quality risk assessment, and tech transfer documents as applicable.
7. Shall coordinate with the cross-functional teams for the implementation of corrective and preventive actions (CAPA).
8. Shall prepare an investigation report with all supporting data.
9. Shall prepare Protocols, SOPs as applicable as a part of CAPA recommendations.
10. Shall follow cGMP and GDP in all investigations
11. Shall undergo mandatory SOP training as per Zydus SOP and also shall undergo training as a part of self-development.
12. Shall execute trend analysis of critical material attributes, critical process parameters, and critical quality attributes by using statistical tools as appropriate
13. Shall be responsible to undergo all training required for the appropriateness of the part B investigation and requirements thereof at Zydus manufacturing facilities
14. Shall be responsible to follow Zydus company policy as appropriate across sites
Qualification: Appropriately Qualified
Experience: 5-10 Years