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Sr. No.
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Job Responsibilities
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To prepare and review central guidance/policies/SOPs for computerized system |
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To prepare validation plan, Validation summary report and System release certificate of centralized GxP software |
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To review and approve software validation deliverables of centralized GxP software |
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To review change controls, Deviation and CAPA of centralized GxP software |
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To carryout software supplier assessment for centralized GxP software |
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To coordinate and conduct training programs and workshop (internal and external) on current cGMP trend, central quality policy, standard practice and directive as and when required. |
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To perform review of computerized systems document with respect to established procedures and current regulatory requirements to assist site user for compliance |
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To ensure shop floor IT compliances at sites such as compliance of IT Standard Operating Procedure, User Access Management, Data center Qualification and Network Qualification. |
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To perform onsite verification of Global CAPA/ Informatics/Quality Intelligence points for computerized system |
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To Provide support to the sites for Regulatory Audit preparation |
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To Providing resolution for queries related to computerized system |
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To proactively identify emerging cGMP requirement with respect to computerized system and implementation as and when required. |
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To perform gap assessment related to Computerized system with respect to regulatory guideline, US FDA 483 form, USFDA warning letter |
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Preparation of informatics status reports for the management as and when required. |
Source: Zydus Lifesciences careers — Read the original posting and apply
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