Location: Corporate Office|Corp. Office, Ahmedabad, Gujarat, India
Skills: GxP software, cGMP, Regulatory Audit, User Access Management, Data center Qualification, Network Qualification
Job Responsibilities
• To prepare and review central guidance/policies/SOPs for computerized system
• To prepare validation plan, Validation summary report and System release certificate of centralized GxP software
• To review and approve software validation deliverables of centralized GxP software
• To review change controls, Deviation and CAPA of centralized GxP software
• To carryout software supplier assessment for centralized GxP software
• 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.
• To perform review of computerized systems document with respect to established procedures and current regulatory requirements to assist site user for compliance
• 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.
• To perform onsite verification of Global CAPA/ Informatics/Quality Intelligence points for computerized system
• To Provide support to the sites for Regulatory Audit preparation
• To Providing resolution for queries related to computerized system
• To proactively identify emerging cGMP requirement with respect to computerized system and implementation as and when required.
• To perform gap assessment related to Computerized system with respect to regulatory guideline, US FDA 483 form, USFDA warning letter
• Preparation of informatics status reports for the management as and when required.