Manager-Quality Informatics

Job Description

Hi, We are having an opening for Manager- Quality Informatics in our IT department at Halol location. Job Summary : Quality Control GxP Systems - Chromatographic & Non chromatographic systems, Data backup, User management, system software trouble shoot (L1), Computer system validation, Regulatory & Customer audits and compliance, QMS related IT (like Change control, Deviation, Investigation) etc. Areas Of Responsibility : Perform in-house software validation, re-validation of computerized systems of QC Lab and Micro area. Initiate and prepare active user list for Laboratory systems & Perform periodic access right and security policy review for Laboratory systems. Implementation of security policies as per site and global procedure. Perform administration activities as per procedure for computerized systems and instruments. Preparation of data backup and restoration procedures. Execution of manual backup and restoration in lab applications as per procedure. Coordinate with Corporate QA IT and QA department for implementation of Global Procedure. Prepare the SOP/CSAP for Lab computerized systems. Updation of roles and privileges as per business owner requirements and to perform validation related activity. Support Infra-IT activities. Authorized to review/ Signoff the documents related to the Quality informatics systems. Knowledge of Empower, Chromeleon, LABX, ICDAS, Lab Solutions. To perform QMS related activity. Educational Qualification : Diploma IT, BE IT, Computer Science Experience : 12 + Years