Assistant Manager

2 weeks ago


India Biocon Full time

Department DetailsRole Summary Maintain inventory list of Scientific and QC applications at Site Assist in 21 CFR Part 11 Assessment during Computerized system selection Prepare and Maintain IT related SOPs as applicable for QC and Scientific automated systems Perform participated into qualification and validation of IT Applications for various IT admin roles Provide IT administrative support on Operating Systems OS of Computer Servers Desktops Laptops Industrial PCs and Handheld devices etc which are used at Site For example o User Management Creation Modification Password reset etc o User Access Rights Management on various drives files and folders o Date and time Management o OS Policy Management o Backup Restoration Management o Installation upgradation of Operating System OS Service Pack Patch Management o Antivirus Management if applicable o Periodic review of event logs as where applicable o Provide support to vendor OEM for fixing IT related issues during breakdowns Perform the data and program backup and retrieval of Scientific Systems as per application SOP s at Site Review and verification of corrective Action plan identified in all Scientific and QC applications during internal and external audits Preparation and Execution of IT SOPs Change Control Deviation and CAPA Data export from OT systems and making it available for cross functional user s process related analysis Initiation of QMS as per IT Operation requirements investigation CAPA implementation Preparation of SOPs as per process development requirements for Information technology Key Responsibilities Maintain inventory list of Scientific and QC applications at Site Assist in 21 CFR Part 11 Assessment during Computerized system selection Prepare and Maintain IT related SOPs as applicable for QC and Scientific automated systems Perform participated into qualification and validation of IT Applications for various IT admin roles Provide IT administrative support on Operating Systems OS of Computer Servers Desktops Laptops Industrial PCs and Handheld devices etc which are used at Site For example o User Management Creation Modification Password reset etc o User Access Rights Management on various drives files and folders o Date and time Management o OS Policy Management o Backup Restoration Management o Installation upgradation of Operating System OS Service Pack Patch Management o Antivirus Management if applicable o Periodic review of event logs as where applicable o Provide support to vendor OEM for fixing IT related issues during breakdowns Perform the data and program backup and retrieval of Scientific Systems as per application SOP s at Site Review and verification of corrective Action plan identified in all Scientific and QC applications during internal and external audits Preparation and Execution of IT SOPs Change Control Deviation and CAPA Data export from OT systems and making it available for cross functional user s process related analysis Initiation of QMS as per IT Operation requirements investigation CAPA implementation Preparation of SOPs as per process development requirements for Information technology Educational QualificationsRequired Education Qualification Required Experience 7 - 9 years Biocon



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