Knowledge Of Software Validation Practices Job Responsibilities 21CFR PART 11 / Annex 11 / 21 CFR PART 211.68 Compliance Gxp Computerized system validation and administration IT Infrastructure project lead for a API manufacturing plant Visakhapatnam Compliance management QMS management I.
e CAPA, QRM, Quality Policies, SOP, cGMP, GDP and Incident and change managements, Followed by GAP analaysis SME For regulatory audits Act as subject matter expert and SPOC for all the IT issues at Site Key Result Areas for the candidate : Manage and monitor GxP- IT Activity, Review the Computer System validation for GxP Systems, Application support to QC and Mfg.
of GxP Systems, Management of Symantec and Acronis Backup software Restore activity with respect to Audit compliance, Administration of Servers, Network and IT Infrastructure, IT- Team Management.
To maintain good IT compliance. Managing leading of Pharma IT Operations Compliance of manufacturing laboratory systems, Computer Systems Compliance (CSV), and Project Management.
Should have enough extensive experience of ERP Systems, Chromatography Systems, Data Acquisition System (DAS), Laboratory information systems, PLC / HMI and SCADA Systems in the regulated environment.
This position is responsible for project and operational support for Technical Software Application / Networking support related to Pharmaceutical facility (Regulatory and functional knowledge of Information Technology department is required).
Information Management System, Work with Business Process Owners to ensure the business requirements implementation, Application uptime, Change request, and Ensure user base is effectively trained and positioned to use all available system functionalities.
Leverage existing applications, systems and processes for increase in utilization. Ensure IT activities are executed according to regulatory requirements and ensuring compliance standards.
Work with Corporate IT to ensure compliance requirements are maintained as desired. Manage the vendors / partners / support to cross functional teams Job Details Posted Date : 2019-11-17Job Location : Delhi, India Job Role : Information TechnologyCompany Industry : Employment Placement Agencies / Recruiting Preferred Candidate Career Level : Director / HeadDegree : Bachelor's degree